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FDA 510(k)

NITRONOX(R), FIRST RESPONSE NITRONOX(TM)

K-Number: K883833 · 1989-02-17

ApplicantMatrix Medica, Inc.
Decision Date1989-02-17
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NITRONOX(R), FIRST RESPONSE NITRONOX(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Medica, Inc.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K883833. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITRONOX(R), FIRST RESPONSE NITRONOX(TM)?

NITRONOX(R), FIRST RESPONSE NITRONOX(TM) is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Matrix Medica, Inc.. The 510(k) number is K883833.

When did NITRONOX(R), FIRST RESPONSE NITRONOX(TM) receive FDA 510(k) clearance?

NITRONOX(R), FIRST RESPONSE NITRONOX(TM) received FDA 510(k) clearance on 1989-02-17, under 510(k) number K883833.

Who is the listed applicant for NITRONOX(R), FIRST RESPONSE NITRONOX(TM)?

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

What is the FDA product code for NITRONOX(R), FIRST RESPONSE NITRONOX(TM)?

The FDA product code for NITRONOX(R), FIRST RESPONSE NITRONOX(TM) is BZR.

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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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