Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012972516

FEI Number

3012972516

Entity Name

Defibtech Branford

City/State/Country

Branford, CT, US

Establishment Address

14 Commercial St, Branford, CT 06405, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DEFIBTECH, LLC (Owner Number: 9048526)

Owner / Operator Contact Address

741 BOSTON POST ROAD, SUITE 201, Guilford, CT 06437, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211289

PMA Number

N/A

All Registered Proprietary Names

Life Scope Pt BSM-1700 Series Bedside Monitor Lifeline View Auto DDU-2200 Fully-Automatic AED Lifeline Auto DDU-120 Fully-Automatic AED DBP-2003 4-year non-rechargeable battery pack DDP-2002 Pediatric Defibrillation Pads Lifeline DDU-100 Semi-Automatic AED Lifeline ECG+ DDU-2475 Semi-Automatic AED DDP-2001 Adult Defibrillation Pads Lifeline ECG DDU-2450 Semi-Automatic AED Lifeline View DDU-2300 Semi-Automatic AED DDP-200P Pediatric Defibrillation Pads DDP-100 Adult Defibrillation Pads DBP-1400 5-year non-rechargeable battery pack DBP-2013 4-year non-rechargeable TSO battery Lifeline PRO DDU-2400 Semi-Automatic AED DBP-2800 7-year non-rechargeable battery pack Lifeline ARM ACC System RMU-1000 Automated Chest Compressor (ACC) System RMU-2000 Automated Chest Compressor (ACC) System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2025-01-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2025-01-13
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-06-27
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2014-10-30
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2023-01-10

Official Correspondent

Robert Jamieson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEFIBTECH, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003521780	DEFIBTECH, LLC	GUILFORD, CT, US
3026976873	DEFIBTECH LLC	N Branford, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012972516. Last updated year: 2026. Please use registration number 3012972516 when referencing this establishment in official correspondence.