TCO2M MODEL 818— 510(k) K791152

Name: FDA 510(k) clearance K791152
Creator: U.S. Food and Drug Administration
Published: 1979-08-03

Substantially Equivalent

Novametrix Medical Systems, Inc.

FDA 510(k) clearance K791152 for TCO2M MODEL 818, Substantially Equivalent on 1979-08-03. Applicant: Novametrix Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Novametrix Medical Systems, Inc.
Product code: Code KLK
Device class: Class 2
Regulation: 21 CFR 868.2500
Advisory panel: Anesthesiology
Date received: 1979-06-19
Decision date: 1979-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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