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FDA 510(k)

MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR

K-Number: K884637 · 1989-01-30

ApplicantAequitron Medical, Inc.
Decision Date1989-01-30
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR 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 1989-01-30 under 510(k) number K884637. 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 9550/9500 RESPIRATION/HEART RATE MONITOR?

MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K884637.

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

MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884637.

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

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 MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR?

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