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FDA 510(k)

HEALTHDYNE MODEL 16900 INFANT MONITOR

K-Number: K821731 · 1982-07-13

ApplicantHealthdyne, Inc.
Decision Date1982-07-13
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEALTHDYNE MODEL 16900 INFANT 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 1982-07-13 under 510(k) number K821731. 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 HEALTHDYNE MODEL 16900 INFANT MONITOR?

HEALTHDYNE MODEL 16900 INFANT MONITOR is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Healthdyne, Inc.. The 510(k) number is K821731.

When did HEALTHDYNE MODEL 16900 INFANT MONITOR receive FDA 510(k) clearance?

HEALTHDYNE MODEL 16900 INFANT MONITOR received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821731.

Who is the listed applicant for HEALTHDYNE MODEL 16900 INFANT 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 HEALTHDYNE MODEL 16900 INFANT MONITOR?

The FDA product code for HEALTHDYNE MODEL 16900 INFANT MONITOR is 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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