510(k) K981800

SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 by Equal Diagnostics, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1998
Date Received
May 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type