FDA 510(k)

NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX

K-Number: K920379 · 1992-07-15

ApplicantNovametrix Medical Systems, Inc.

Decision Date1992-07-15

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX 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 1992-07-15 under 510(k) number K920379. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX?

NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX is a medical device that received FDA 510(k) clearance on 1992-07-15. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K920379.

When did NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX receive FDA 510(k) clearance?

NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX received FDA 510(k) clearance on 1992-07-15, under 510(k) number K920379.

Who is the listed applicant for NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX?

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 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX?

The FDA product code for NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX is DQA.

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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.