POCKETCPR

Device Classification Name

aid, cardiopulmonary resuscitation

510(k) Number K071321
Device Name POCKETCPR
Applicant
BIO-DETEK, INC.
525 narragansett park dr.
pawtucket, 
RI 
02861 -4323

Applicant Contact mark totman
Correspondent
BIO-DETEK, INC.
525 narragansett park dr.
pawtucket, 
RI 
02861 -4323

Correspodent Contact mark totman
Regulation Number 870.5200
Classification Product Code
LIX  
Date Received 05/10/2007
Decision Date 09/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No