THERMAMED BATH— 510(k) K833631

Substantially Equivalent

Bernlit Enterprises, Inc.

FDA 510(k) clearance K833631 for THERMAMED BATH, Substantially Equivalent on 1983-11-28. Applicant: Bernlit Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Bernlit Enterprises, Inc.
Product code: Code IMC
Device class: Class 2
Regulation: 21 CFR 890.5110
Advisory panel: Physical Medicine
Date received: 1983-10-17
Decision date: 1983-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.