TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM— 510(k) K940160

Name: FDA 510(k) clearance K940160
Creator: U.S. Food and Drug Administration
Published: 1994-05-27

Substantially Equivalent

Burke Neutech, Inc.

FDA 510(k) clearance K940160 for TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM, Substantially Equivalent on 1994-05-27. Applicant: Burke Neutech, Inc.. Device class: 2.

Clearance details

Applicant: Burke Neutech, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1994-01-12
Decision date: 1994-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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