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Healthcare Logistics Systems: FDA-registered device maker in Coral Springs, FL, United States, 10 510(k) clearances

Name: Healthcare Logistics Systems FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Healthcare Logistics Systems is registered with the FDA (registration 3005873568) in Coral Springs, FL, United States. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 3, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005873568
Address: 4348 NW 120TH Ave, Coral Springs, FL, United States, 33065
Owner or operator: Healthcare Logistics Systems (9091182)
Roles: Complaint file establishment
First device listed: September 21, 2017
Registered through: 2026
Brand names listed: 2100, 2101, Capox, Handheld Pro, NightOwl, SPo2T, Sleepifi Dream, Spirit and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Complaint file establishment	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Complaint file establishment	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Complaint file establishment	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
October 3, 2024	K240808	Pulse Oximeter (WS20A)	DQA	Substantially Equivalent	Hunan Accurate Bio-Medical Technology Co., Ltd.	accessdata.fda.gov
April 8, 2022	K202389	Oxygen Concentrator	CAW	Substantially Equivalent	Foshan Mic Medical Technology Co., Ltd.	accessdata.fda.gov
March 6, 2020	K191031	NightOwl	MNR	Substantially Equivalent	Ectosense NV	accessdata.fda.gov
December 2, 2019	K191088	Checkme O2 Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov
August 31, 2018	K173368	Reusable & Disposable SpO2 Sensors	DQA	Substantially Equivalent	Shenzhen Coreray Technology, Ltd.	accessdata.fda.gov
July 18, 2018	K170820	Capnograph and Oximeter	CCK	Substantially Equivalent	Cmi Health, Inc.	accessdata.fda.gov
April 18, 2016	K152563	Pulse Oximeter (MD300M/MD300K2)	DQA	Substantially Equivalent	Beijing Choice Electronic Technology Co., Ltd.	accessdata.fda.gov
June 11, 2009	K090671	PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
April 3, 2009	K083466	MD2000A VITAL SIGN MONITOR, MODEL MD2000A	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 3, 2024. 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.