The following data is part of a premarket notification filed by Impeto Medical Inc with the FDA for Sudoscan.
| Device ID | K141872 |
| 510k Number | K141872 |
| Device Name: | SUDOSCAN |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | IMPETO MEDICAL INC 400 N. WASHINGTON ST., STE 100 MEDICAL DEVICES DIVISION Alexandria, VA 22314 |
| Contact | Calley Herzog |
| Correspondent | Calley Herzog IMPETO MEDICAL INC 400 N. WASHINGTON ST., STE 100 MEDICAL DEVICES DIVISION Alexandria, VA 22314 |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2014-11-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUDOSCAN 79100037 4181325 Live/Registered |
IMPETO MEDICAL 2011-05-25 |