510(k) K840469

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

K840469 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "TYCOS SELF CHECK BPM3 BLOOD PRESS MONI". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Sybron Corp. has at least 10 other 510(k) clearances on record.

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