SUDOSCAN
Device, Galvanic Skin Response Measurement
IMPETO MEDICAL
The following data is part of a premarket notification filed by Impeto Medical with the FDA for Sudoscan.
Pre-market Notification Details
| Device ID | K100233 |
| 510k Number | K100233 |
| Device Name: | SUDOSCAN |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | IMPETO MEDICAL 4479 SHOREPOINTS WAY San Diego, CA 92130 |
| Contact | Kye Cheung |
| Correspondent | Kye Cheung IMPETO MEDICAL 4479 SHOREPOINTS WAY San Diego, CA 92130 |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-26 |
| Decision Date | 2010-06-14 |
| Summary: | summary |
Trademark Results [SUDOSCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUDOSCAN 79100037 4181325 Live/Registered |
IMPETO MEDICAL 2011-05-25 |
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