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FDA 510(k)

TRIMED 510 APNEA MONITOR

K-Number: K822819 · 1982-11-04

ApplicantTri-Med, Inc.
Decision Date1982-11-04
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRIMED 510 APNEA MONITOR 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 1982-11-04 under 510(k) number K822819. 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 TRIMED 510 APNEA MONITOR?

TRIMED 510 APNEA MONITOR is a medical device that received FDA 510(k) clearance on 1982-11-04. The listed applicant is Tri-Med, Inc.. The 510(k) number is K822819.

When did TRIMED 510 APNEA MONITOR receive FDA 510(k) clearance?

TRIMED 510 APNEA MONITOR received FDA 510(k) clearance on 1982-11-04, under 510(k) number K822819.

Who is the listed applicant for TRIMED 510 APNEA MONITOR?

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 TRIMED 510 APNEA MONITOR?

The FDA product code for TRIMED 510 APNEA MONITOR is BZQ.

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Other records listing Tri-Med, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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