DELTA THERM COLD THERAPY SYSTEM— 510(k) K945399

Name: FDA 510(k) clearance K945399
Creator: U.S. Food and Drug Administration
Published: 1995-03-07

Substantially Equivalent for Some Indications

Deltatherm

FDA 510(k) clearance K945399 for DELTA THERM COLD THERAPY SYSTEM, Substantially Equivalent for Some Indications on 1995-03-07. Applicant: Deltatherm. Device class: 2.

Clearance details

Applicant: Deltatherm
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1994-11-04
Decision date: 1995-03-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Pittsburgh, PA, US

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