510(k) K822614

BLOOD PRESSURE MONITORING DEVICES by Allied Healthcare Products, Inc. — Product Code DXN

K822614 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "BLOOD PRESSURE MONITORING DEVICES". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
August 30, 1982
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