Epic Systems Corporation

Verona, WI, US

EPIC SYSTEMS CORPORATION appears in FDA device records in Verona, WI. FDA records list 3 510(k) clearances between 1991-11-19 and 1993-01-07, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Epic Systems Corporation between 1991 and 1993. The busiest year on record is 1991, with 1. The most recent is 1993, with 1.

Clearances by year, as a table

510(k) clearance decisions for Epic Systems Corporation, by decision year
Year	Clearances
1991	1
1992	1
1993	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K922783	ES1700 ECG MODULATOR	DXH	Substantially Equivalent	1993-01-07
K921699	ES 1500 ECG DEMODULATOR	DXH	Substantially Equivalent	1992-12-17
K912281	ES1600 PARAMEDIC TELEPHONE	DXH	Substantially Equivalent	1991-11-19

Registered establishments

FDA registered establishments for Epic Systems Corporation, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3006365377	3006365377	EPIC SYSTEMS CORPORATION	1979 Milky Way, Verona, WI 53593 US	2026	FXN MMH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain