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FDA 510(k)

OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700

K-Number: K981725 · 1999-02-02

ApplicantOptovent, Inc.
Decision Date1999-02-02
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 is the device name listed in this FDA 510(k) record. The listed applicant is Optovent, Inc.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K981725. 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 OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700?

OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Optovent, Inc.. The 510(k) number is K981725.

When did OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 receive FDA 510(k) clearance?

OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 received FDA 510(k) clearance on 1999-02-02, under 510(k) number K981725.

Who is the listed applicant for OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700?

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

What is the FDA product code for OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700?

The FDA product code for OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 is BZQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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