The following data is part of a premarket notification filed by Woundvision, Llc with the FDA for Wound Measuring & Monitoring Device.
| Device ID | K131596 |
| 510k Number | K131596 |
| Device Name: | WOUND MEASURING & MONITORING DEVICE |
| Classification | Tape, Camera, Surgical |
| Applicant | WOUNDVISION, LLC 29 EAST MCCARTY STREET SUITE 100 Indianapolis, IN 46225 |
| Contact | Gretchen Miller Bowker |
| Correspondent | Gretchen Miller Bowker WOUNDVISION, LLC 29 EAST MCCARTY STREET SUITE 100 Indianapolis, IN 46225 |
| Product Code | FXN |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-12-11 |
| Summary: | summary |