510(k) K771561

DOVER URINE METER by Will Ross Co. — Product Code EXR

K771561 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "DOVER URINE METER". The FDA issued a decision of Substantially Equivalent on September 7, 1977. The device falls under product code EXR (Urinometer, Mechanical), a Class II device regulated under 21 CFR 876.1800. Will Ross Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1977
Date Received
August 15, 1977
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