The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 2500a Palmsat Pulse Oximeter.
| Device ID | K050056 |
| 510k Number | K050056 |
| Device Name: | MODEL 2500A PALMSAT PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori Roth |
| Correspondent | Lori 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-11 |
| Decision Date | 2005-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166000689 | K050056 | 000 |
| 00849686090178 | K050056 | 000 |
| 00849686071375 | K050056 | 000 |
| 00849686050929 | K050056 | 000 |