Applied Cardiac Systems, Inc.

Matched from indexed company URL: APPLIED CARDIAC SYSTEMS

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2024089	2024089	Applied Cardiac Systems, Inc.	1	N	2026-01-01	25651 Atlantic Ocean Dr Ste 14-15a Lake Forest CA US 92630

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00853512007001	CORE12 - Multi Function Device	9499006144	mwright@appliedcardiacsystems.com

appliedcardiacsystems.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
34426	1818129600	K860249	THE HOLTER REPORTER (TM)	DPS	1986-03-11
34426	1807414752	K103706	THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR	QYX	2011-08-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
QYX	1	2011-08-24
DPS	1	1986-03-11

PMN#

THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
2011-08-24
APPLIED CARDIAC SYSTEMS, INC.
ACS MODEL NCP-2
2004-12-09
APPLIED CARDIAC SYSTEMS
THE HOLTER REPORTER (TM)
1986-03-11
APPLIED CARDIAC SYSTEMS
HOLTER PERFORMER FEATHER WEIGHT/CASS
1983-12-01
APPLIED CARDIAC SYSTEMS
HOLTER PERFORMER
1982-01-29
APPLIED CARDIAC SYSTEMS

GUDID#

CORE12 - Multi Function Device
APPLIED CARDIAC SYSTEMS, INC.
2018-03-27