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 |