Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K923305 |
Device Name |
BATTERY PACKS |
Applicant |
ACCESS / GOD LOVES YOU |
P.O. BOX 1630 |
CASTLE ROCK,
CO
80104
|
|
Applicant Contact |
GWEEN REED |
Correspondent |
ACCESS / GOD LOVES YOU |
P.O. BOX 1630 |
CASTLE ROCK,
CO
80104
|
|
Correspondent Contact |
GWEEN REED |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 06/18/1992 |
Decision Date | 12/17/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|