NOVATRACER RECORDER— 510(k) K811453

Name: FDA 510(k) clearance K811453
Creator: U.S. Food and Drug Administration
Published: 1981-07-10

Substantially Equivalent

Novametrix Medical Systems, Inc.

FDA 510(k) clearance K811453 for NOVATRACER RECORDER, Substantially Equivalent on 1981-07-10. Applicant: Novametrix Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Novametrix Medical Systems, Inc.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1981-05-22
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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