OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700— 510(k) K981725

Name: FDA 510(k) clearance K981725
Creator: U.S. Food and Drug Administration
Published: 1999-02-02

Substantially Equivalent

Optovent, Inc.

FDA 510(k) clearance K981725 for OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700, Substantially Equivalent on 1999-02-02. Applicant: Optovent, Inc.. Device class: 2.

Clearance details

Applicant: Optovent, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1998-05-15
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lee, NJ, US

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