510(k) K181497
K181497 is an FDA 510(k) premarket notification submitted by BTL Industries, Inc. for the device "HPM-6000UF". The FDA issued a decision of Substantially Equivalent on Nov 14, 2018. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. BTL Industries, Inc. has 45 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 14, 2018
- Date Received
- Jun 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type
- 510(k)