The following data is part of a premarket notification filed by Medic-aid Ltd. with the FDA for System 22 Adult Mask.
| Device ID | K940887 |
| 510k Number | K940887 |
| Device Name: | SYSTEM 22 ADULT MASK |
| Classification | Mask, Oxygen |
| Applicant | MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp, GB |
| Contact | Howard B Burnett |
| Correspondent | Howard B Burnett MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp, GB |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-25 |
| Decision Date | 1994-04-19 |