BT-400— 510(k) K142332

Substantially Equivalent

Bio-Med USA

FDA 510(k) clearance K142332 for BT-400, Substantially Equivalent on 2015-03-20. Applicant: Bio-Med USA.

Clearance details

Applicant: Bio-Med USA
Product code: Code LBI
Advisory panel: General Hospital
Date received: 2014-08-20
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, NJ, US

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