The following data is part of a premarket notification filed by Med-life, Inc. with the FDA for Med-life Emergency Oxygen Regreather/resuscitator.
| Device ID | K844420 |
| 510k Number | K844420 |
| Device Name: | MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MED-LIFE, INC. 4520 WOODBEND Bryan, TX 77803 |
| Contact | Donald W Welch |
| Correspondent | Donald W Welch MED-LIFE, INC. 4520 WOODBEND Bryan, TX 77803 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-15 |
| Decision Date | 1984-12-17 |