AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION— 510(k) K964697

Substantially Equivalent

Advance Medical Device, Inc.

FDA 510(k) clearance K964697 for AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION, Substantially Equivalent on 1997-02-11. Applicant: Advance Medical Device, Inc..

Clearance details

Applicant: Advance Medical Device, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1996-11-22
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.