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 |