The following data is part of a premarket notification filed by Nonin Medical Inc. with the FDA for Sensmart Model 8203ca Regional Oximetry Sensor (adult/pediatric, >40 Kg, Sensmart Model 820ca Regional Oximetry Sensor (adult/pediatric, >40 Kg).
| Device ID | K151305 |
| 510k Number | K151305 |
| Device Name: | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 Kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 Kg) |
| Classification | Oximeter, Tissue Saturation |
| Applicant | NONIN MEDICAL INC. 13700 1ST AVENUE NORTH Plymouth, MN 55441 |
| Contact | Laura J. Lind |
| Correspondent | Laura J. Lind NONIN MEDICAL INC. 13700 1ST AVENUE NORTH Plymouth, MN 55441 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-08-27 |
| Summary: | summary |