510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K152973Substantially Equivalent

Dyna-Vision Telemonitoring System

Techmedic Development International B.V., Broek Op Langedijk, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152973 is the FDA 510(k) clearance record for Dyna-Vision Telemonitoring System, a class II device, cleared for Techmedic Development International B.V. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list one 510(k) clearance for Techmedic Development International B.V. As of , FDA records show no recalls naming K152973.

Clearance record

Decision date
Received
(204 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Techmedic Development International B.V. Broeker Werf 6, Broek Op Langedijk, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20260