DEFIBRILLATOR ANALYZER – DA-2006P


Device Classification Name

tester, defibrillator

510(k) Number K110192
Device Name DEFIBRILLATOR ANALYZER – DA-2006P
Applicant
BC GROUP INTERNATIONAL, INC
2913 209th lane nw
oak grove, 
MN 
55011

Applicant Contact jack slovick
Regulation Number 870.5325
Classification Product Code
DRL  
Date Received 01/24/2011
Decision Date 02/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No