The following data is part of a premarket notification filed by Medical Repair Service, Inc. with the FDA for Oxlife.
| Device ID | K904271 |
| 510k Number | K904271 |
| Device Name: | OXLIFE |
| Classification | Generator, Oxygen, Portable |
| Applicant | MEDICAL REPAIR SERVICE, INC. 4470 HANCOCK BRIDGE PKWY. N. Ft. Myers, FL 33903 |
| Contact | Stuart Bassine |
| Correspondent | Stuart Bassine MEDICAL REPAIR SERVICE, INC. 4470 HANCOCK BRIDGE PKWY. N. Ft. Myers, FL 33903 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-17 |
| Decision Date | 1990-10-12 |