The following data is part of a premarket notification filed by Visual Footcare Technologies, Llc with the FDA for Visual Footcare Technologies Tempstat.
| Device ID | K080816 |
| 510k Number | K080816 |
| Device Name: | VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT |
| Classification | Foot Examination Tool For Inflammatory Changes |
| Applicant | VISUAL FOOTCARE TECHNOLOGIES, LLC P.O. BOX 760 South Salem, NY 10590 |
| Contact | Andrew Singer |
| Correspondent | Andrew Singer VISUAL FOOTCARE TECHNOLOGIES, LLC P.O. BOX 760 South Salem, NY 10590 |
| Product Code | OIZ |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-06-24 |
| Summary: | summary |