The following data is part of a premarket notification filed by Kent Imaging with the FDA for Snapshotnir.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B376KD2040 | K201976 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SNAPSHOTNIR 88164613 not registered Live/Pending |
Kent Imaging Inc. 2018-10-22 |