IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER— 510(k) K941404

Name: FDA 510(k) clearance K941404
Creator: U.S. Food and Drug Administration
Published: 1994-06-29

Substantially Equivalent

Hogan & Hartson

FDA 510(k) clearance K941404 for IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER, Substantially Equivalent on 1994-06-29. Applicant: Hogan & Hartson. Device class: 2.

Clearance details

Applicant: Hogan & Hartson
Product code: Code DRL
Device class: Class 2
Regulation: 21 CFR 870.5325
Advisory panel: Cardiovascular
Date received: 1994-03-23
Decision date: 1994-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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