510(k) K881630

AUTOMATIC CALORIC IRRIGATION SYSTEM by Ics Medical Corp. — Product Code KHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
April 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Caloric-Air
Device Class
Class I
Regulation Number
874.1800
Review Panel
EN
Submission Type