The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Mark-5 Concentrator.
| Device ID | K883591 |
| 510k Number | K883591 |
| Device Name: | MARK-5 CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | NIDEK MEDICAL PRODUCTS, INC. 2706 S. 19TH ST. Birmingham, AL 35209 |
| Contact | Don Hunter |
| Correspondent | Don Hunter NIDEK MEDICAL PRODUCTS, INC. 2706 S. 19TH ST. Birmingham, AL 35209 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-23 |
| Decision Date | 1988-11-02 |