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FDA 510(k)

INFANT MONITOR 16900

K-Number: K843546 · 1984-10-10

ApplicantHealthdyne, Inc.
Decision Date1984-10-10
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT MONITOR 16900 is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1984-10-10 under 510(k) number K843546. 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 INFANT MONITOR 16900?

INFANT MONITOR 16900 is a medical device that received FDA 510(k) clearance on 1984-10-10. The listed applicant is Healthdyne, Inc.. The 510(k) number is K843546.

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

INFANT MONITOR 16900 received FDA 510(k) clearance on 1984-10-10, under 510(k) number K843546.

Who is the listed applicant for INFANT MONITOR 16900?

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 INFANT MONITOR 16900?

The FDA product code for INFANT MONITOR 16900 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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