510(k) K840469

TYCOS SELF CHECK BPM3 BLOOD PRESS MONI by Sybron Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
February 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type