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FDA 510(k)

COSMO PLUS WITH NICO, MODEL 8200

K-Number: K982499 · 1998-10-16

ApplicantNovametrix Medical Systems, Inc.
Decision Date1998-10-16
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COSMO PLUS WITH NICO, MODEL 8200 is the device name listed in this FDA 510(k) record. The listed applicant is Novametrix Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K982499. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMO PLUS WITH NICO, MODEL 8200?

COSMO PLUS WITH NICO, MODEL 8200 is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K982499.

When did COSMO PLUS WITH NICO, MODEL 8200 receive FDA 510(k) clearance?

COSMO PLUS WITH NICO, MODEL 8200 received FDA 510(k) clearance on 1998-10-16, under 510(k) number K982499.

Who is the listed applicant for COSMO PLUS WITH NICO, MODEL 8200?

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

What is the FDA product code for COSMO PLUS WITH NICO, MODEL 8200?

The FDA product code for COSMO PLUS WITH NICO, MODEL 8200 is BZC.

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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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