Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K931484 |
Device Name |
REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S |
Applicant |
PORTABLE POWER SYSTEMS, INC. |
1940 TEE LN. |
CASTLE ROCK,
CO
80104
|
|
Applicant Contact |
NORMAN A PREMO |
Correspondent |
PORTABLE POWER SYSTEMS, INC. |
1940 TEE LN. |
CASTLE ROCK,
CO
80104
|
|
Correspondent Contact |
NORMAN A PREMO |
Regulation Number | 868.5905
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/1993 |
Decision Date | 02/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|