The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 8500 Hand Held Pulse Oximeter.
| Device ID | K893221 |
| 510k Number | K893221 |
| Device Name: | MODEL 8500 HAND HELD PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 12900 HIGHWAY 55 Minneapolis, MN 55441 |
| Contact | Neal F Nordling |
| Correspondent | Neal F Nordling NONIN MEDICAL, INC. 12900 HIGHWAY 55 Minneapolis, MN 55441 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-27 |
| Decision Date | 1990-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166003567 | K893221 | 000 |
| 00833166000078 | K893221 | 000 |