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FDA 510(k)

AS165 RESPIRATION MONITOR

K-Number: K861743 · 1986-05-09

ApplicantAir-Shields, Inc.
Decision Date1986-05-09
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AS165 RESPIRATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K861743. 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 AS165 RESPIRATION MONITOR?

AS165 RESPIRATION MONITOR is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is Air-Shields, Inc.. The 510(k) number is K861743.

When did AS165 RESPIRATION MONITOR receive FDA 510(k) clearance?

AS165 RESPIRATION MONITOR received FDA 510(k) clearance on 1986-05-09, under 510(k) number K861743.

Who is the listed applicant for AS165 RESPIRATION MONITOR?

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

What is the FDA product code for AS165 RESPIRATION MONITOR?

The FDA product code for AS165 RESPIRATION MONITOR is 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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