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Model 9200 Respiration/Heart Rate Monitor

by Aequitron Medical, Inc.

510(k) K901656

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 NumberK901656 Date13 Jul 1990ClearedStatusActive

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  • Withdrawn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
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits.

This device is supplied as a non-sterile, reusable monitor for use in clinical settings. It is classified as FDA Class 2 under product code BZQ and regulation number 868.2375, with FDA 510(k) clearance K901656 granted on July 13, 1990, and is not an apnea monitor as defined in § 868.2377.

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Questions

AI-generated answers, 26 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 MODEL 9200 RESPIRATION/HEART RATE MONITOR used for?

    The MODEL 9200 RESPIRATION/HEART RATE MONITOR is intended to measure or monitor a patient's respiratory rate. It provides an audible or visible alarm when the respiratory rate, averaged over time, falls outside operator-settable alarm limits, helping clinicians detect abnormal breathing patterns in clinical settings.

  • Is the MODEL 9200 RESPIRATION/HEART RATE MONITOR sterile or non-sterile, and is it reusable?

    The MODEL 9200 RESPIRATION/HEART RATE MONITOR is supplied as a non-sterile device and is designed for reuse in clinical settings. It must be cleaned and disinfected according to the manufacturer's instructions between uses to maintain functionality and safety.

  • What regulatory pathway and classification apply to the MODEL 9200 RESPIRATION/HEART RATE MONITOR?

    The MODEL 9200 RESPIRATION/HEART RATE MONITOR received FDA 510(k) clearance under K901656 on July 13, 1990, and is classified as FDA Class 2 under product code BZQ and regulation number 868.2375. It was found substantially equivalent to a predicate device and is not classified as an apnea monitor under § 868.2377.