ARTOCOOL-S WATER CIRCULATING COLD PACK— 510(k) K964354

Name: FDA 510(k) clearance K964354
Creator: U.S. Food and Drug Administration
Published: 1997-08-29

Substantially Equivalent

Ormed GmbH

FDA 510(k) clearance K964354 for ARTOCOOL-S WATER CIRCULATING COLD PACK, Substantially Equivalent on 1997-08-29. Applicant: Ormed GmbH. Device class: 2.

Clearance details

Applicant: Ormed GmbH
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1996-10-31
Decision date: 1997-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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