The following data is part of a premarket notification filed by Soterix Medical,inc. with the FDA for Iontodc.
| Device ID | K170291 |
| 510k Number | K170291 |
| Device Name: | IontoDC |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | SOTERIX MEDICAL,INC. 237 W 35 ST, 1401 New York, NY 10001 |
| Contact | Abhishek Datta |
| Correspondent | Abhishek Datta SOTERIX MEDICAL,INC. 237 W 35 ST, 1401 New York, NY 10001 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-05-01 |
| Summary: | summary |