Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
510(k) Number |
K000275 |
Device Name |
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA |
Applicant |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
DANIEL KOSEDNAR |
Correspondent |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
DANIEL KOSEDNAR |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 01/31/2000 |
Decision Date | 04/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|