The following data is part of a premarket notification filed by Advanced Tactile Imaging, Inc. with the FDA for Vaginal Tactile Imager.
| Device ID | K142355 |
| 510k Number | K142355 |
| Device Name: | Vaginal Tactile Imager |
| Classification | Perineometer |
| Applicant | Advanced Tactile Imaging, Inc. 1459 Lower Ferry Raod Trenton, NJ 08618 |
| Contact | Vladimir Egorov |
| Correspondent | Vladimir Egorov Advanced Tactile Imaging, Inc. 1459 Lower Ferry Raod Trenton, NJ 08618 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2015-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864124000106 | K142355 | 000 |