T-350 THERAPEUTIC COOLING MACHINE— 510(k) K950711

Name: FDA 510(k) clearance K950711
Creator: U.S. Food and Drug Administration
Published: 1995-07-06

Substantially Equivalent

Thermotek, Inc.

FDA 510(k) clearance K950711 for T-350 THERAPEUTIC COOLING MACHINE, Substantially Equivalent on 1995-07-06. Applicant: Thermotek, Inc.. Device class: 2.

Clearance details

Applicant: Thermotek, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1995-02-14
Decision date: 1995-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

Download summary PDF View on FDA.gov ↗

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