NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2— 510(k) K844253

Name: FDA 510(k) clearance K844253
Creator: U.S. Food and Drug Administration
Published: 1985-01-10

Substantially Equivalent

Novametrix Medical Systems, Inc.

FDA 510(k) clearance K844253 for NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2, Substantially Equivalent on 1985-01-10. 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: 1984-11-02
Decision date: 1985-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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