EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)— 510(k) K980725

Name: FDA 510(k) clearance K980725
Creator: U.S. Food and Drug Administration
Published: 1998-08-24

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K980725 for EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A), Substantially Equivalent on 1998-08-24. Applicant: Instrumentation Industries, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1998-02-24
Decision date: 1998-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

Download summary PDF View on FDA.gov ↗

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