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FDA 510(k)

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)

K-Number: K811265 · 1981-06-02

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

Device Summary

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) 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 K811265. 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 (MODEL 409 W/NASOPH.)?

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) 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 K811265.

When did RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) receive FDA 510(k) clearance?

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) received FDA 510(k) clearance on 1981-06-02, under 510(k) number K811265.

Who is the listed applicant for RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)?

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 (MODEL 409 W/NASOPH.)?

The FDA product code for RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) is BZQ.

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Other records listing Impact Instrumentation, 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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