510(k) K002061

A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR by A&D Engineering, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2001
Date Received
July 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type