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 |