510(k) K942485
K942485 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT UROLOGY TABLE". The FDA issued a decision of Substantially Equivalent on August 26, 1994. The device falls under product code MMZ (Table, Cystometric, Electric), a Class II device regulated under 21 CFR 876.4890. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1994
- Date Received
- May 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Cystometric, Electric
- Device Class
- Class II
- Regulation Number
- 876.4890
- Review Panel
- GU
- Submission Type