Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K993656 |
Device Name |
DATEX-OHMEDA TONOMETRY MODULE M-TONO |
Applicant |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
JOEL C KENT |
Correspondent |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
JOEL C KENT |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 10/29/1999 |
Decision Date | 03/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|