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H-H Harris Neonatal Nasal Cannula Set For Cpap

by Holter-Hausner Intl.

510(k) K871351

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871351 Date14 May 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZD
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The H-H Harris Neonatal Nasal Cannula Set For Cpap is a ventilator, non-continuous (respirator) device used in the medical specialty of Anesthesiology. It is designed for neonatal use and is intended to provide continuous positive airway pressure (CPAP).

The device is supplied with a product code of BZD and is regulated under regulation number 868.5905. It has been cleared by the FDA with a 510(k) number of K871351, with a decision date of May 14, 1987. The device is classified as substantially equivalent (SESE) and is used in anesthesiology settings.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the H-H Harris Neonatal Nasal Cannula Set For Cpap used for?

    The H-H Harris Neonatal Nasal Cannula Set For Cpap is used to provide continuous positive airway pressure (CPAP) for neonatal patients in anesthesiology settings.

  • Is the H-H Harris Neonatal Nasal Cannula Set For Cpap cleared by the FDA?

    Yes, the device has been cleared by the FDA with a 510(k) number of K871351, indicating it is substantially equivalent to a predicate device.

  • What product code is assigned to the H-H Harris Neonatal Nasal Cannula Set For Cpap?

    The device is assigned a product code of BZD and is regulated under regulation number 868.5905.