The following data is part of a premarket notification filed by Spectralmd, Inc. with the FDA for Spectralmd Deepview Wound Imaging System 2.0.
| Device ID | K163339 |
| 510k Number | K163339 |
| Device Name: | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | SPECTRALMD, INC. 2515 MCKINNEY AVENUE Dallas, TX 75201 |
| Contact | J. Michael Dimaio |
| Correspondent | J. Michael Dimaio SPECTRALMD, INC. 2515 MCKINNEY AVENUE Dallas, TX 75201 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-28 |
| Decision Date | 2017-08-17 |
| Summary: | summary |