The following data is part of a premarket notification filed by Kee Medical Services, Inc. with the FDA for K.e.e. Oxygen Concentrator.
| Device ID | K894384 |
| 510k Number | K894384 |
| Device Name: | K.E.E. OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | KEE MEDICAL SERVICES, INC. 8 BELVEDERE DR. Mechanicsburg, PA 17055 |
| Contact | Stephen M Green |
| Correspondent | Stephen M Green KEE MEDICAL SERVICES, INC. 8 BELVEDERE DR. Mechanicsburg, PA 17055 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-10-27 |