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FDA 510(k)

MODEL 900S APNEA/HEART MONITOR

K-Number: K903287 · 1990-08-17

ApplicantHealthdyne, Inc.
Decision Date1990-08-17
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 900S APNEA/HEART MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K903287. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 900S APNEA/HEART MONITOR?

MODEL 900S APNEA/HEART MONITOR is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Healthdyne, Inc.. The 510(k) number is K903287.

When did MODEL 900S APNEA/HEART MONITOR receive FDA 510(k) clearance?

MODEL 900S APNEA/HEART MONITOR received FDA 510(k) clearance on 1990-08-17, under 510(k) number K903287.

Who is the listed applicant for MODEL 900S APNEA/HEART MONITOR?

The FDA 510(k) record lists Healthdyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 900S APNEA/HEART MONITOR?

The FDA product code for MODEL 900S APNEA/HEART MONITOR is BZQ.

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Related Devices (Code: BZQ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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