The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter.
| Device ID | K080255 |
| 510k Number | K080255 |
| Device Name: | NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori M Roth |
| Correspondent | Lori M Roth NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166000757 | K080255 | 000 |
| 00833166000740 | K080255 | 000 |
| 00833166004588 | K080255 | 000 |
| 00833166004557 | K080255 | 000 |
| 00849686050936 | K080255 | 000 |
| 00849686073133 | K080255 | 000 |
| 00849686074413 | K080255 | 000 |