Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
510(k) Number |
K012924 |
Device Name |
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER |
Applicant |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
BILL EXNER |
Correspondent |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
BILL EXNER |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 08/31/2001 |
Decision Date | 01/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|