COOL 'N HEAT MACHINE— 510(k) K891151

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K891151 for COOL 'N HEAT MACHINE, Substantially Equivalent on 1989-04-06. Applicant: Kinetic Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1989-03-03
Decision date: 1989-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, 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.