Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K931355 |
Device Name |
WHISPER O2 |
Applicant |
TRILOGIC CORP. |
8175 GRANT WAY |
LITTLETON,
CO
80122
|
|
Applicant Contact |
DAVE AUBURN |
Correspondent |
TRILOGIC CORP. |
8175 GRANT WAY |
LITTLETON,
CO
80122
|
|
Correspondent Contact |
DAVE AUBURN |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 03/17/1993 |
Decision Date | 03/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|