Data / Medical devices / United States / Jpex Medical Equipment & Supplies, Inc.

Jpex Medical Equipment & Supplies, Inc.: FDA-registered device maker in Ronkonkoma, NY, United States, 9 510(k) clearances

Name: Jpex Medical Equipment & Supplies, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jpex Medical Equipment & Supplies, Inc. is registered with the FDA (registration 3016931915) in Ronkonkoma, NY, United States. It lists 10 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 5, 2019. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016931915
Address: 2140 Pond Rd Unit 5, Ronkonkoma, NY, United States, 11779
Owner or operator: JPEX Medical Equipment & Supplies, Inc. (10074703)
Roles: Repackager or relabeler
First device listed: May 28, 2020
Registered through: 2026
Brand names listed: JPX-380AT, 380AT, V9 Vital Signs Monitor

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Repackager or relabeler	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph	DPS	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 5, 2019	K181919	Patient Monitor	MWI	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
February 25, 2016	K153135	VITAL SIGNS MONITOR	MWI	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
February 13, 2015	K141946	DIGITAL ELECTROCARDIOGRAPH	DPS	Substantially Equivalent	Shenzhen Biocare Bio-Medical Equipment Co., Ltd.	accessdata.fda.gov
February 18, 2014	K131898	A SERIES AND Q SERIES PATIENT MONITORS	MWI	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
October 1, 2013	K123711	PATIENT MONITOR	MWI	Substantially Equivalent	Shenzhen Creative Industry Co., Ltd.	accessdata.fda.gov
October 24, 2011	K112803	PATIENT MONITOR	MHX	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
April 8, 2010	K100046	M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000	MHX	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
February 2, 2010	K092970	GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H	MHX	Substantially Equivalent	General Meditech, Inc.	accessdata.fda.gov
January 7, 2009	K082789	G1B PULSE OXIMETER	DQA	Substantially Equivalent	General Meditech, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 5, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.