The following data is part of a premarket notification filed by Cpr Medical Devices, Inc. with the FDA for Oxylator Em-100.
| Device ID | K944349 |
| 510k Number | K944349 |
| Device Name: | OXYLATOR EM-100 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | CPR MEDICAL DEVICES, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson CPR MEDICAL DEVICES, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-06 |
| Decision Date | 1995-04-17 |