The following data is part of a premarket notification filed by Hypermed Imaging, Inc. with the FDA for Hyperview Hyperspectral Tissue Oxygenation Measurement System.
| Device ID | K161237 |
| 510k Number | K161237 |
| Device Name: | HyperView Hyperspectral Tissue Oxygenation Measurement System |
| Classification | Oximeter, Tissue Saturation |
| Applicant | HYPERMED IMAGING, INC. 8700 TRAIL LAKE DR WEST, SUITE 200 Memphis, TN 38125 |
| Contact | Carlyn Reynolds |
| Correspondent | Julie Powell EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869661000251 | K161237 | 000 |
| 00869661000244 | K161237 | 000 |
| 00869661000237 | K161237 | 000 |
| 00869661000220 | K161237 | 000 |
| 00869661000213 | K161237 | 000 |
| 00869661000206 | K161237 | 000 |