A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS

System, Measurement, Blood-pressure, Non-invasive

A & D ENGINEERING, INC.

The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A & D Medicallifesource Us-779pc & Ua-779t Digital Blood Pressure Monitors.

Pre-market Notification Details

Device IDK993888
510k NumberK993888
Device Name:A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas,  CA  95035
ContactJerry Wang
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-11-16
Decision Date1999-12-20

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