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FDA 510(k)

RESPIRATION & HEART RATE MONITOR 530

K-Number: K843681 · 1984-12-04

ApplicantTri-Med, Inc.
Decision Date1984-12-04
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION & HEART RATE MONITOR 530 is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med, Inc.. It received FDA 510(k) clearance on 1984-12-04 under 510(k) number K843681. 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 530?

RESPIRATION & HEART RATE MONITOR 530 is a medical device that received FDA 510(k) clearance on 1984-12-04. The listed applicant is Tri-Med, Inc.. The 510(k) number is K843681.

When did RESPIRATION & HEART RATE MONITOR 530 receive FDA 510(k) clearance?

RESPIRATION & HEART RATE MONITOR 530 received FDA 510(k) clearance on 1984-12-04, under 510(k) number K843681.

Who is the listed applicant for RESPIRATION & HEART RATE MONITOR 530?

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

What is the FDA product code for RESPIRATION & HEART RATE MONITOR 530?

The FDA product code for RESPIRATION & HEART RATE MONITOR 530 is BZQ.

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Other records listing Tri-Med, Inc. as applicant

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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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