510(k) K934142

URINARY DRAINAGE BAG by Key Medical Services, Inc. — Product Code EXR

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