The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Patient Valve With Air Entrainment.
| Device ID | K863410 |
| 510k Number | K863410 |
| Device Name: | PATIENT VALVE WITH AIR ENTRAINMENT |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | PNEU PAC, LTD. CRESCENT RD. Luton Beds Lu2 Oah, GB |
| Contact | Weiss |
| Correspondent | Weiss PNEU PAC, LTD. CRESCENT RD. Luton Beds Lu2 Oah, GB |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-23 |
| Decision Date | 1987-01-12 |