510(k) K884915

DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER by Dantec Electronics, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type