Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1527715

FEI Number

1527715

Entity Name

SCOTTCARE CORPORATION

City/State/Country

CLEVELAND, OH, US

Establishment Address

4791 WEST 150TH ST., CLEVELAND, OH 44135, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ScottCare Corporation (Owner Number: 9915036)

Owner / Operator Contact Address

4791 W150th Street, --, Cleveland, OH 44135, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021517

PMA Number

N/A

All Registered Proprietary Names

153+ TeleSentry Dynavision Holter Plus HolterCare Chroma Chroma2 EZ Link NetLink/ NetScan EventCare OneView TTM for Windows+ ABP For Windows ABPCare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2007-11-27
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2010-12-13
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2010-12-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2007-11-27
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2009-11-23
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2007-11-27
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2008-01-29
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2007-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ScottCare Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K891148	Del Mar Avionics	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	1989-05-11
K914092	Nihon Kohden America, Inc.	BSM-2100A CONFIGURED PATIENT MONITOR	1992-05-28
K153473	Braemar Manufacturing, LLC	Braemar Telemetry Patch System	2016-07-22
K151681	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-07-17
K150310	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2025	Philips North America	2	IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05	General Electric Medical Systems Information Technology	2	GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025	Philips North America	2	Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

Similar Registrations

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3030721635	ICENTIA LLC	Burlington, VT, US
3003971136	EDAN INSTRUMENTS, INC.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1527715. Last updated year: 2026. Please use registration number 1527715 when referencing this establishment in official correspondence.