MARK VII THERMOREGULATION ASSIST SYSTEM— 510(k) K900355

Name: FDA 510(k) clearance K900355
Creator: U.S. Food and Drug Administration
Published: 1990-02-15

Substantially Equivalent

Life Enhancement Technologies, LLC

FDA 510(k) clearance K900355 for MARK VII THERMOREGULATION ASSIST SYSTEM, Substantially Equivalent on 1990-02-15. Applicant: Life Enhancement Technologies, LLC. Device class: 2.

Clearance details

Applicant: Life Enhancement Technologies, LLC
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1990-01-25
Decision date: 1990-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, 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.