Defibrillator Analyzer Variable Load— 510(k) K153210

Substantially Equivalent

Bc Group International, Inc.

FDA 510(k) clearance K153210 for Defibrillator Analyzer Variable Load, Substantially Equivalent on 2015-12-21. Applicant: Bc Group International, Inc.. Device class: 2.

Clearance details

Applicant
Bc Group International, Inc.
Product code
Code DRL
Device class
Class 2
Regulation
21 CFR 870.5325
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saint Charles, MO, US
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