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FDA 510(k)

RESPIRATORY SENSOR

K-Number: K811014 · 1981-06-02

ApplicantImpact Instrumentation, Inc.
Decision Date1981-06-02
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Impact Instrumentation, Inc.. It received FDA 510(k) clearance on 1981-06-02 under 510(k) number K811014. 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 RESPIRATORY SENSOR?

RESPIRATORY SENSOR is a medical device that received FDA 510(k) clearance on 1981-06-02. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K811014.

When did RESPIRATORY SENSOR receive FDA 510(k) clearance?

RESPIRATORY SENSOR received FDA 510(k) clearance on 1981-06-02, under 510(k) number K811014.

Who is the listed applicant for RESPIRATORY SENSOR?

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

What is the FDA product code for RESPIRATORY SENSOR?

The FDA product code for RESPIRATORY SENSOR is BZQ.

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Other records listing Impact Instrumentation, Inc. as applicant

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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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