The following data is part of a premarket notification filed by Delphi Medical Systems with the FDA for Portable Oxygen Concentrator, Model Rs-00400.
| Device ID | K073242 |
| 510k Number | K073242 |
| Device Name: | PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 |
| Classification | Generator, Oxygen, Portable |
| Applicant | DELPHI MEDICAL SYSTEMS 5725 DELPHI DRIVE Troy, MI 48098 |
| Contact | Gilbert Roque |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2008-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867460000137 | K073242 | 000 |
| 00867460000106 | K073242 | 000 |