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FDA 510(k)

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S

K-Number: K892006 · 1989-05-23

ApplicantHealthdyne, Inc.
Decision Date1989-05-23
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1989-05-23 under 510(k) number K892006. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S?

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Healthdyne, Inc.. The 510(k) number is K892006.

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

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S received FDA 510(k) clearance on 1989-05-23, under 510(k) number K892006.

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

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'S APNEA/HEART MONITOR, MODEL 900S?

The FDA product code for HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S is DRT.

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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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