Device Classification Name |
analyzer, gas, carbon-monoxide, gaseous-phase
|
510(k) Number |
K833739 |
Device Name |
CD-102 CARBON DIOXIDE ANALYZER/RECOR |
Applicant |
INSTRUMENTARIUM CORP. |
2 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent |
INSTRUMENTARIUM CORP. |
2 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Regulation Number | 868.1430
|
Classification Product Code |
|
Date Received | 10/25/1983 |
Decision Date | 12/16/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|