The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 6100c Series Single-patient Use, Disposable Pulse Oximeter Sensors (6100c Series: 6100ca, 6100cp, 6100ci, 6100cn), Model 6101c Series Single-patient Use, Disposable Pulse Oximeter Sensors (6101c Series: 6101ca, 6101cp, 6101ci, 6101cn), Model 61.
| Device ID | K160865 |
| 510k Number | K160865 |
| Device Name: | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 61 |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 |
| Contact | Nancy E. Deangelo |
| Correspondent | Nancy E. Deangelo NONIN MEDICAL, INC. 13700 1ST AVE. 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 | 2016-03-30 |
| Decision Date | 2016-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166008494 | K160865 | 000 |