THERMOSUIT SYSTEM— 510(k) K061023

Name: FDA 510(k) clearance K061023
Creator: U.S. Food and Drug Administration
Published: 2006-09-20

Substantially Equivalent

Life Recovery Systems Hd, LLC

FDA 510(k) clearance K061023 for THERMOSUIT SYSTEM, Substantially Equivalent on 2006-09-20. Applicant: Life Recovery Systems Hd, LLC. Device class: 2.

Clearance details

Applicant: Life Recovery Systems Hd, LLC
Product code: Code NZE
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2006-04-13
Decision date: 2006-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, CT, 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.