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FDA 510(k)

RESPIRATORY CARE MONITOR

K-Number: K812977 · 1981-11-16

ApplicantAdvanced Medical Equipment, Inc.
Decision Date1981-11-16
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY CARE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Equipment, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812977. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY CARE MONITOR?

RESPIRATORY CARE MONITOR is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Advanced Medical Equipment, Inc.. The 510(k) number is K812977.

When did RESPIRATORY CARE MONITOR receive FDA 510(k) clearance?

RESPIRATORY CARE MONITOR received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812977.

Who is the listed applicant for RESPIRATORY CARE MONITOR?

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

What is the FDA product code for RESPIRATORY CARE MONITOR?

The FDA product code for RESPIRATORY CARE MONITOR is BZA.

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Related Devices (Code: BZA)

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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