Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009503584

FEI Number

3009503584

Entity Name

HCLTech

City/State/Country

Pittston, PA, US

Establishment Address

248 Armstrong Rd, Pittston, PA 18640, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

HCL America, Inc. (Owner Number: 10084715)

Owner / Operator Contact Address

248 Armstong Road, Pittston, PA 18640, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173510

PMA Number

N/A

All Registered Proprietary Names

BioStamp NPoint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-03-24
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2022-03-24
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2022-03-24
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2022-03-24

Official Correspondent

Heather Ferrence

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HCL America, 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
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11
K113105	Remote Diagnostic Technologies , Ltd.	TEMPUSIC PATIENT MONITOR	2011-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

Similar Registrations

Registration Number	Establishment Name	Location
3033118181	CHERO TECHNOLOGY CO., LTD.	Jiaxing Zhejiang, CN
3026960443	Cicor Medtec Bucharest	Bucharest Bucuresti, RO
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009503584. Last updated year: 2026. Please use registration number 3009503584 when referencing this establishment in official correspondence.