510(k) K896958

ESCORT NON-INVASIVE BLOOD PRESSURE OPTION by Medical Data Electronics — Product Code DXN

K896958 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "ESCORT NON-INVASIVE BLOOD PRESSURE OPTION". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Medical Data Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
December 14, 1989
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