510(k) K801723

UR 150-UR 150T by Siemens Corp. — Product Code KQS

K801723 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "UR 150-UR 150T". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
July 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type