510(k) K810944
K810944 is an FDA 510(k) premarket notification submitted by Medical Monitoring Systems, Inc. for the device "PENILE ERECTION MONITOR". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Medical Monitoring Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- April 7, 1981
- 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