Device Classification Name |
Bag, Reservoir
|
510(k) Number |
K830056 |
Device Name |
ARTEC TWIST VALVE |
Applicant |
ARTEC ENVIRONMENTAL MONITORING DIVISION |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ARTEC ENVIRONMENTAL MONITORING DIVISION |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5320
|
Classification Product Code |
|
Date Received | 01/06/1983 |
Decision Date | 03/09/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|