510(k) K142355
K142355 is an FDA 510(k) premarket notification submitted by Advanced Tactile Imaging, Inc. for the device "Vaginal Tactile Imager". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Advanced Tactile Imaging, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2015
- Date Received
- August 25, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type