510(k) K890330

MEDILOG 6000-FD REPORT GENERATOR by Oxford Medilog, Inc. — Product Code DSI

K890330 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "MEDILOG 6000-FD REPORT GENERATOR". The FDA issued a decision of Substantially Equivalent on April 20, 1989. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1989
Date Received
January 23, 1989
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