510(k) K851646
K851646 is an FDA 510(k) premarket notification submitted by Multicept, Aps. for the device "VIBRECTOR". The FDA issued a decision of Substantially Equivalent on August 21, 1985. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Multicept, Aps. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1985
- Date Received
- April 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Penile Tumescence
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type