510(k) K880903
K880903 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD (R) ESKA ERECTIOMETER". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1988
- Date Received
- March 2, 1988
- 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