510(k) K934142
K934142 is an FDA 510(k) premarket notification submitted by Key Medical Services, Inc. for the device "URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on May 17, 1994. The device falls under product code EXR (Urinometer, Mechanical), a Class II device regulated under 21 CFR 876.1800. Key Medical Services, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1994
- Date Received
- August 25, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urinometer, Mechanical
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type