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FDA 510(k)

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550

K-Number: K903020 · 1991-04-10

ApplicantAequitron Medical, Inc.
Decision Date1991-04-10
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1991-04-10 under 510(k) number K903020. 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 RESPIRATION/HEART RATE MONITOR MODEL 9500/9550?

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 is a medical device that received FDA 510(k) clearance on 1991-04-10. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K903020.

When did RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 receive FDA 510(k) clearance?

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 received FDA 510(k) clearance on 1991-04-10, under 510(k) number K903020.

Who is the listed applicant for RESPIRATION/HEART RATE MONITOR MODEL 9500/9550?

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

What is the FDA product code for RESPIRATION/HEART RATE MONITOR MODEL 9500/9550?

The FDA product code for RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 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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