The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Nuvo Nano Portable Oxygen Concentrator.
| Device ID | K192693 |
| 510k Number | K192693 |
| Device Name: | Nuvo Nano Portable Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Brimingham, AL 35217 |
| Contact | Olivia Mullen |
| Correspondent | Olivia Mullen Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Brimingham, AL 35217 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00038214002466 | K192693 | 000 |