The following data is part of a premarket notification filed by Artec Environmental Monitoring Division with the FDA for Anesthesia Shutoff Valve Positive Closure.
| Device ID | K854573 |
| 510k Number | K854573 |
| Device Name: | ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | ARTEC ENVIRONMENTAL MONITORING DIVISION P.O. BOX 68 Noblesville, IN 46060 |
| Contact | Bill Wingler |
| Correspondent | Bill Wingler ARTEC ENVIRONMENTAL MONITORING DIVISION P.O. BOX 68 Noblesville, IN 46060 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-14 |
| Decision Date | 1986-01-03 |