The following data is part of a premarket notification filed by Medway with the FDA for Medway Oxygen Mask.
| Device ID | K931952 |
| 510k Number | K931952 |
| Device Name: | MEDWAY OXYGEN MASK |
| Classification | Mask, Oxygen |
| Applicant | MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
| Contact | James Callaway |
| Correspondent | James Callaway MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-20 |
| Decision Date | 1993-08-20 |