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Cpap Humidifier (Hc 200)

by Fisher & Paykel Electronics, Ltd. New Zealand 510(k)

510(k) K973161 Product code BZD

Overview

The Cpap Humidifier (Hc 200) is a combined Continuous Positive Airway Pressure Blower and Heated Respiratory Humidifier. It is classified as a Ventilator, Non-Continuous (Respirator) with a product code of Bzd and regulation number 868.5905. The device is used in the medical specialty of Anesthesiology.

The Cpap Humidifier (Hc 200) is supplied with an instruction sheet that provides information on how to use and maintain the device. It has been cleared by the FDA under the 510(k) clearance K973161. The device is intended for use in a healthcare setting and is subject to the regulations outlined in 21 Cfr §868.5905. The manufacturer, Fisher & Paykel Electronics, Ltd, provides a comprehensive operating manual for the Sleepstyle 200 Series Humidified Cpap System, which includes the Cpap Humidifier (Hc 200).

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973161 Date10 Jul 1998ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
BZD
FDA applicant
Fisher & Paykel Electronics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Fisher & Paykel Electronics, Ltd.

See all devices from Fisher & Paykel Electronics, Ltd. →

Questions

  • What is the Cpap Humidifier HC 200 used for?

    The Cpap Humidifier HC 200 is used in the medical specialty of Anesthesiology to provide Continuous Positive Airway Pressure and heated respiratory humidification.

  • Is the Cpap Humidifier HC 200 supplied with instructions?

    Yes, the Cpap Humidifier HC 200 is supplied with an instruction sheet that provides information on how to use and maintain the device.

  • What is the regulatory classification of the Cpap Humidifier HC 200?

    The Cpap Humidifier HC 200 is classified as a Ventilator, Non-Continuous (Respirator) with a product code of BZD and regulation number 868.5905.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K973161 24 fields · synced 22 Oct 2026