510(k) K941105
K941105 is an FDA 510(k) premarket notification submitted by Laborie Medical Tech, Inc. for the device "UORCAP,MODEL NUMBER UDS-UCAP". The FDA issued a decision of Substantially Equivalent on May 10, 1994. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Laborie Medical Tech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 1994
- Date Received
- March 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Uroflowmeter
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type