SnapshotNIR
Oximeter, Tissue Saturation
Kent Imaging
The following data is part of a premarket notification filed by Kent Imaging with the FDA for Snapshotnir.
Pre-market Notification Details
| Device ID | K201976 |
| 510k Number | K201976 |
| Device Name: | SnapshotNIR |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Kent Imaging 804B 16th Ave SW Calgary, CA T2r 0s9 |
| Contact | Liz Newell |
| Correspondent | Liz Newell Kent Imaging 804B 16th Ave SW Calgary, CA T2r 0s9 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-16 |
| Decision Date | 2020-11-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B376KD2040 | K201976 | 000 |
Trademark Results [SnapshotNIR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SNAPSHOTNIR 88164613 not registered Live/Pending |
Kent Imaging Inc. 2018-10-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.