510(k) K896102

MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR by Advanced Medical Products, Inc. — Product Code DXN

K896102 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
October 23, 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