The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Mark 5 Nuvo Lite Ocsi And Std.
| Device ID | K082566 |
| 510k Number | K082566 |
| Device Name: | MARK 5 NUVO LITE OCSI AND STD |
| Classification | Generator, Oxygen, Portable |
| Applicant | NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Contact | Jennifer Mcwilliams |
| Correspondent | Jennifer Mcwilliams 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-04 |
| Decision Date | 2008-12-03 |
| Summary: | summary |