PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR— 510(k) K946080

Name: FDA 510(k) clearance K946080
Creator: U.S. Food and Drug Administration
Published: 1995-08-02

Substantially Equivalent

Portable Power Systems, Inc.

FDA 510(k) clearance K946080 for PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR, Substantially Equivalent on 1995-08-02. Applicant: Portable Power Systems, Inc.. Device class: 1.

Clearance details

Applicant: Portable Power Systems, Inc.
Product code: Code FCO
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-12-13
Decision date: 1995-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castle Rock, CO, US

Download summary PDF View on FDA.gov ↗

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