510(k) K942485

MDT UROLOGY TABLE by Mdt Corp., Inc. — Product Code MMZ

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