SPAULDING MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008921101	3008921101	SPAULDING MEDICAL, LLC	1	N	2026-01-01	111 Heritage Reserve Menomonee Falls WI US 53051

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
B441BTAHA0	Spaulding Electrocardiograph - The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECGmanagement solution. (Medical Device Data System) The light weight and portable SpauldingElectrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)information to the WebECG system and receives a report back from the WebECG system.The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ orWindows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable andstrategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a12-lead ECG.	18886077871	clientservices@spauldingclinical.com
B441BTIEC0	Spaulding Electrocardiograph - The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECGmanagement solution. (Medical Device Data System) The light weight and portable SpauldingElectrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)information to the WebECG system and receives a report back from the WebECG system.The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ orWindows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable andstrategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a12-lead ECG.	18886077871	clientservices@spauldingclinical.com

spauldingclinical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
218747	1345022442	K150564	Spaulding Electrocardiograph 2100iQ	DPS	2015-08-12
218747	2053284991

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DPS	1	2015-08-12

GUDID#

Spaulding Client App - Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.

SPAULDING MEDICAL, LLC

2020-04-02

Spaulding Client App - Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.

SPAULDING MEDICAL, LLC

2020-04-02

Spaulding Client App - Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.

SPAULDING MEDICAL, LLC

2020-04-02

Spaulding Electrocardiograph - The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECGmanagement solution. (Medical Device Data System) The light weight and portable SpauldingElectrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)information to the WebECG system and receives a report back from the WebECG system.The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ orWindows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable andstrategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a12-lead ECG.

SPAULDING MEDICAL, LLC

2017-03-16

Spaulding Electrocardiograph - The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECGmanagement solution. (Medical Device Data System) The light weight and portable SpauldingElectrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)information to the WebECG system and receives a report back from the WebECG system.The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ orWindows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable andstrategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a12-lead ECG.

SPAULDING MEDICAL, LLC

2017-03-16

Spaulding Electrocardiograph - The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.

SPAULDING MEDICAL, LLC

2017-03-14