510(k) K931574
K931574 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Ltd. for the device "ADVANCE MODEL UDS-ADV". The FDA issued a decision of Substantially Equivalent on August 5, 1993. The device falls under product code EXQ (Cystometer, Electrical Recording), a Class II device regulated under 21 CFR 876.1620. Laborie Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1993
- Date Received
- March 30, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystometer, Electrical Recording
- Device Class
- Class II
- Regulation Number
- 876.1620
- Review Panel
- GU
- Submission Type