510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964697Substantially Equivalent

Amd Home Health Monitor System and Amd Monitoring Station

Advance Medical Device, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964697 is the FDA 510(k) clearance record for AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION, a class II device, cleared for Advance Medical Device, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 5 510(k) clearances for Advance Medical Device, Inc., from to . As of , FDA records show no recalls naming K964697.

Clearance record

Decision date
Received
(81 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Advance Medical Device, Inc. 152 W. Wisconsin Ave., Milwaukee WI
510(k) summary
Statement
Third party review
No

Clearances, product code DXN

Trailing 12 months
29 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20260