The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for H500 Multi-sensing Oximetry System.
| Device ID | K192900 |
| 510k Number | K192900 |
| Device Name: | H500 Multi-Sensing Oximetry System |
| Classification | Oximeter |
| Applicant | Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441 |
| Contact | Kim E Aves |
| Correspondent | Brent Geiger Nonin Medical, Inc. 13700 1st Avenue North Plymouth, 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 | 2019-10-15 |
| Decision Date | 2020-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849686051094 | K192900 | 000 |
| 00849686051063 | K192900 | 000 |
| 00849686051049 | K192900 | 000 |
| 00849686051032 | K192900 | 000 |