The following data is part of a premarket notification filed by Medical Electronic Devices, Inc. with the FDA for Pulsed Oxygen Conserving Device, Pocd.
| Device ID | K983459 |
| 510k Number | K983459 |
| Device Name: | PULSED OXYGEN CONSERVING DEVICE, POCD |
| Classification | Conserver, Oxygen |
| Applicant | MEDICAL ELECTRONIC DEVICES, INC. 2807 OREGON CT. #D6 Torrance, CA 90503 |
| Contact | Thomas Wenzel |
| Correspondent | Thomas Wenzel MEDICAL ELECTRONIC DEVICES, INC. 2807 OREGON CT. #D6 Torrance, CA 90503 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-12-08 |
| Summary: | summary |