Healthcare Logistics Systems

FDA Device Registration & Listing · CORAL SPRINGS, FL, US · Registration 3005873568

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005873568
FEI Number
3005873568
Entity Name
Healthcare Logistics Systems
City/State/Country
CORAL SPRINGS, FL, US
Establishment Address
4348 NW 120TH AVE, CORAL SPRINGS, FL 33065, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Healthcare Logistics Systems (Owner Number: 9091182)
Owner / Operator Contact Address
5850 Coral Ridge Dr., Suite 304, Coral Springs, FL 33076, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K170820
PMA Number
N/A

All Registered Proprietary Names

2100 2101 SPo2T NightOwl VirtuSLEEP Vital Pro Handheld Pro Sleepifi Dream Capox

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2023-10-09
DQA Oximeter Cardiovascular Class 2 870.2700 2020-08-07
DQA Oximeter Cardiovascular Class 2 870.2700 2018-11-07
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2020-05-15
DQA Oximeter Cardiovascular Class 2 870.2700 2025-11-24
DQA Oximeter Cardiovascular Class 2 870.2700 2017-09-21
DQA Oximeter Cardiovascular Class 2 870.2700 2018-02-13
DQA Oximeter Cardiovascular Class 2 870.2700 2025-04-18
DQA Oximeter Cardiovascular Class 2 870.2700 2024-04-11
DQA Oximeter Cardiovascular Class 2 870.2700 2020-01-16
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-01-16

Official Correspondent

Daniel Labi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Healthcare Logistics Systems
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
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

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3018783526 CEVA LOGISTICS NETHERLANDS BV (Venray) Oostrum Limburgh, NL
2085602 FISHER & PAYKEL HEALTHCARE, INC. IRVINE, CA, US
3015084765 GUANG DONG EDA TECHNOLOGY CO., LTD. Dongguan City Guangdong, CN
3009831876 MASIMO CORPORATION Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005873568. Last updated year: 2026. Please use registration number 3005873568 when referencing this establishment in official correspondence.
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