510(k) K003576

Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 by Quinton, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2001
Date Received
November 20, 2000
Clearance Type
Abbreviated
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