| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K854573 |
| Device Name |
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE |
| Applicant |
| Artec Environmental Monitoring Division |
| P.O. Box 68 |
|
Noblesville,
IN
46060
|
|
| Applicant Contact |
BILL WINGLER |
| Correspondent |
| Artec Environmental Monitoring Division |
| P.O. Box 68 |
|
Noblesville,
IN
46060
|
|
| Correspondent Contact |
BILL WINGLER |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 11/14/1985 |
| Decision Date | 01/03/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|