510(k) K880391

DACOMED CYSTOMETER by Dacomed Corp. — Product Code EXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1988
Date Received
January 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometer, Electrical Recording
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type