Device Classification Name |
Mixer, Breathing Gases, Anesthesia Inhalation
|
510(k) Number |
K974372 |
Device Name |
AIR OXYGE MIXER |
Applicant |
SK MED |
16000 SHERMAN WAY #224 |
VAN NUYS,
CA
91406
|
|
Applicant Contact |
DIPAK GHOSH |
Correspondent |
SK MED |
16000 SHERMAN WAY #224 |
VAN NUYS,
CA
91406
|
|
Correspondent Contact |
DIPAK GHOSH |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 11/20/1997 |
Decision Date | 02/05/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|