The following data is part of a premarket notification filed by Advantage Medical Services, Inc. with the FDA for Swift Infant Oxygen Hood-reusable (modification).
| Device ID | K955482 |
| 510k Number | K955482 |
| Device Name: | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) |
| Classification | Hood, Oxygen, Infant |
| Applicant | ADVANTAGE MEDICAL SERVICES, INC. 19380 HIGHWAY B Edgerton, MO 64444 |
| Contact | M B Fisher |
| Correspondent | M B Fisher ADVANTAGE MEDICAL SERVICES, INC. 19380 HIGHWAY B Edgerton, MO 64444 |
| Product Code | FOG |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-01-30 |