Device Classification Name |
Box, Battery, Rechargeable
|
510(k) Number |
K946080 |
Device Name |
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR |
Applicant |
PORTABLE POWER SYSTEMS, INC. |
1940 TEE LN. |
CASTLE ROCK,
CO
80104
|
|
Applicant Contact |
NORMAN A PREMOP |
Correspondent |
PORTABLE POWER SYSTEMS, INC. |
1940 TEE LN. |
CASTLE ROCK,
CO
80104
|
|
Correspondent Contact |
NORMAN A PREMOP |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/13/1994 |
Decision Date | 08/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|