510(k) K141893
K141893 is an FDA 510(k) premarket notification submitted by Bioinfinity (M) Sdn. Bhd. for the device "VIBRANCE KEGEL DEVICE (VKD)". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Bioinfinity (M) Sdn. Bhd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2014
- Date Received
- July 14, 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