510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K172965Substantially Equivalent

Handheld VitalSigns Monitoring System

Visiomed Technology Co.,Ltd, Bao An, Shenzhen,, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172965 is the FDA 510(k) clearance record for Handheld VitalSigns Monitoring System, a class II device, cleared for Visiomed Technology Co.,Ltd on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list one 510(k) clearance for Visiomed Technology Co.,Ltd. As of , FDA records show no recalls naming K172965.

Clearance record

Decision date
Received
(447 days to decision)
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Visiomed Technology Co.,Ltd 2 Floor Of #1 Bldg.,, Bao An, Shenzhen,, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWI

Trailing 12 months
5 clearances under product code MWI in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260