Skip to content

Spiromate AS-600

by Riko Medical & Scientific Instrument Corp.

510(k) K862023

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 NumberK862023 Date17 Jun 1986ClearedStatusActive

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  • Withdrawn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
BZG
Device Class
Class II
Regulation
21 CFR Part 868.1840
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Spiromate AS-600 is a diagnostic spirometer used for measuring lung function. It is designed to assess respiratory parameters through spirometry testing.

The device is supplied by Riko Medical & Scientific Instrument Corp. and has FDA 510(k) clearance with product code BZG under regulation number 868.1840. It is classified as a Class II medical device and is intended for use in anesthesiology settings.

Other devices from Riko Medical & Scientific Instrument Corp.

Questions

AI-generated answers, 25 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 SPIROMATE AS-600 used for?

    The SPIROMATE AS-600 is a diagnostic spirometer designed to measure lung function through spirometry testing, specifically intended for use in anesthesiology settings to assess respiratory parameters.

  • How is the SPIROMATE AS-600 supplied?

    The SPIROMATE AS-600 is supplied by Riko Medical & Scientific Instrument Corp., located at 3000 Marcus Ave., Lake Success, NY 11042, with contact person Norman Kanesaka.

  • What is the regulatory status of the SPIROMATE AS-600?

    The SPIROMATE AS-600 has FDA 510(k) clearance with product code BZG under regulation number 868.1840, classified as a Class II medical device, and received clearance on June 17, 1986.

  • Is the SPIROMATE AS-600 reusable or single-use?

    The device data does not specify whether the SPIROMATE AS-600 is designed for single-use or multiple uses, as this information is not provided in the regulatory documentation.