TEMPTEK T-1000 THERAPEUTIC COOLING UNIT— 510(k) K891091

Name: FDA 510(k) clearance K891091
Creator: U.S. Food and Drug Administration
Published: 1990-03-26

Substantially Equivalent

Temptek, Inc.

FDA 510(k) clearance K891091 for TEMPTEK T-1000 THERAPEUTIC COOLING UNIT, Substantially Equivalent on 1990-03-26. Applicant: Temptek, Inc.. Device class: 2.

Clearance details

Applicant: Temptek, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1989-03-02
Decision date: 1990-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.