Amd Home Health Monitor System and Amd Monitoring Station

FDA 510(k) K964697 · Advance Medical Device, Inc.

Substantially Equivalent

510(k) numberK964697

Submission

Device name
Amd Home Health Monitor System and Amd Monitoring Station
Applicant
Advance Medical Device, Inc.
Milwaukee, WI, US
Received
November 22, 1996
Decision date
February 11, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

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Questions and answers

When was Amd Home Health Monitor System and Amd Monitoring Station cleared by the FDA?

Amd Home Health Monitor System and Amd Monitoring Station (K964697) received a 510(k) decision of Substantially Equivalent on February 11, 1997, 81 days after the submission was received.

What is the product code of K964697?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.