The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite Std.
| Device ID | K123738 |
| 510k Number | K123738 |
| Device Name: | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD |
| Classification | Generator, Oxygen, Portable |
| Applicant | NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Contact | Van Muth |
| Correspondent | Van Muth NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-05 |
| Decision Date | 2013-02-28 |
| Summary: | summary |