510(k) K882206

SUPERMON ARRHYTHMIA MODULE 7270 by Kontron Instruments, Inc. — Product Code DSI

K882206 is an FDA 510(k) premarket notification submitted by Kontron Instruments, Inc. for the device "SUPERMON ARRHYTHMIA MODULE 7270". The FDA issued a decision of Substantially Equivalent on April 5, 1989. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Kontron Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1989
Date Received
May 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type