NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS— 510(k) K081693

Name: FDA 510(k) clearance K081693
Creator: U.S. Food and Drug Administration
Published: 2008-09-11

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K081693 for NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS, Substantially Equivalent on 2008-09-11. Applicant: Instrumentation Industries, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BXR
Device class: Class 2
Regulation: 21 CFR 868.1780
Advisory panel: Anesthesiology
Date received: 2008-06-17
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

Download summary PDF View on FDA.gov ↗

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