510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K946115Substantially Equivalent

Ek-View(tm) ECG Management System

Apcot Medical Systems, Philadelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946115 is the FDA 510(k) clearance record for EK-VIEW(TM) ECG MANAGEMENT SYSTEM, a class II device, cleared for Apcot Medical Systems on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list one 510(k) clearance for Apcot Medical Systems. As of , FDA records show no recalls naming K946115.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Apcot Medical Systems 3508 Market St., Philadelphia PA
510(k) summary
Statement
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260