Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010112812

FEI Number

3010112812

Entity Name

INFOBIONIC, INC.

City/State/Country

Chelmsford, MA, US

Establishment Address

321 Billerica Rd, Office Link #5, Chelmsford, MA 01824, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

InfoBionic, Inc. (Owner Number: 10051518)

Owner / Operator Contact Address

321 Billerica Rd, Office Link #5, Chelmsford, MA 01824, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250356

PMA Number

N/A

All Registered Proprietary Names

MoMe ARC Wireless Ambulatory ECG Monitoring and Detection System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2025-08-20

Official Correspondent

Laura Leal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InfoBionic, Inc.

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

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3009499478	EDAN Diagnostics, Inc.	San Diego, CA, US
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010112812. Last updated year: 2026. Please use registration number 3010112812 when referencing this establishment in official correspondence.