EPIC SYSTEMS CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3006365377	3006365377	EPIC SYSTEMS CORPORATION	1	N	2027-01-01	1979 Milky Way Verona WI US 53593

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
170034	1234437097	K260008	Deterioration Index Version 2	QNL	2026-09-18
170034	1781846794	BK241081
170034	1064627626	BK200482
170034	1663091697	BK170032
170034	1686931742	BK130037
170034	1352229168

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
QNL	1	2026-09-18

PMN#

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
2020-06-10
Epic Systems Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
2017-06-28
Epic Systems Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
2014-03-06
Epic Systems Corporation

GUDID#

Blood Product Administration Module - 4
EPIC SYSTEMS CORPORATION
2025-02-03
Automated Wound Measurements - 1
EPIC SYSTEMS CORPORATION
2025-02-03
Blood Product Administration Module - 2
EPIC SYSTEMS CORPORATION
2023-06-19
Blood Product Administration Module - 3
EPIC SYSTEMS CORPORATION
2020-11-02