The following data is part of a premarket notification filed by Kent Imaging Inc. with the FDA for Kent Camera.
| Device ID | K163070 |
| 510k Number | K163070 |
| Device Name: | Kent Camera |
| Classification | Oximeter, Tissue Saturation |
| Applicant | KENT IMAGING INC. 1440, 720- 13TH AVENUE SW Calgary, CA T2r 1m5 |
| Contact | Darrell Barnhart |
| Correspondent | Darrell Barnhart KENT IMAGING INC. 1440, 720- 13TH AVENUE SW Calgary, CA T2r 1m5 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2017-05-05 |
| Summary: | summary |