The following data is part of a premarket notification filed by Eagle Medical Equipment Co. with the FDA for Oxypulse Eoc I, Eoc Ii & Eoc R.
| Device ID | K955129 |
| 510k Number | K955129 |
| Device Name: | OXYPULSE EOC I, EOC II & EOC R |
| Classification | Conserver, Oxygen |
| Applicant | EAGLE MEDICAL EQUIPMENT CO. 3134 W. LEWIS #30 Phx, AZ 85017 |
| Contact | Lawrence Pellerito |
| Correspondent | Lawrence Pellerito EAGLE MEDICAL EQUIPMENT CO. 3134 W. LEWIS #30 Phx, AZ 85017 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-09 |
| Decision Date | 1996-02-16 |