EP AMP, MODEL #901— 510(k) K925346

Name: FDA 510(k) clearance K925346
Creator: U.S. Food and Drug Administration
Published: 1993-04-30

Substantially Equivalent

Quinton Electrophysiology Corp.

FDA 510(k) clearance K925346 for EP AMP, MODEL #901, Substantially Equivalent on 1993-04-30. Applicant: Quinton Electrophysiology Corp.. Device class: 2.

Clearance details

Applicant: Quinton Electrophysiology Corp.
Product code: Code DRR
Device class: Class 2
Regulation: 21 CFR 870.2050
Advisory panel: Cardiovascular
Date received: 1992-10-22
Decision date: 1993-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

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