Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K925580 |
Device Name |
OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD |
Applicant |
OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP |
P.O. BOX 7550 |
OHMEDA DRIVE |
MADISON,
WI
53707
|
|
Applicant Contact |
GRAHAM B LUKEY |
Correspondent |
OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP |
P.O. BOX 7550 |
OHMEDA DRIVE |
MADISON,
WI
53707
|
|
Correspondent Contact |
GRAHAM B LUKEY |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 11/04/1992 |
Decision Date | 06/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|