CABLES AND SENSORS, LLC

FDA Device Registration & Listing · Orlando, FL, US · Registration 3008595074

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
3008595074
FEI Number
3008595074
Entity Name
CABLES AND SENSORS, LLC
City/State/Country
Orlando, FL, US
Establishment Address
5874 S SEMORAN BLVD, Orlando, FL 32822, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Cables and Sensors, LLC (Owner Number: 10039590)
Owner / Operator Contact Address
5874 S Semoran Blvd, Orlando, FL 32822, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K083448
PMA Number
N/A

All Registered Proprietary Names

Cables and Sensors pulse oximeter cable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2021-10-11
DQA Oximeter Cardiovascular Class 2 870.2700 2024-07-02

Official Correspondent

Diego Orjuela

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cables and Sensors, 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
3016096099 C&S Manufacturing International SRL de CV Torreon Coahuila, MX

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

Registration Number Establishment Name Location
3014652024 CEA GROUP INTERNATIONAL CO.,LTD Wenzhou Zhejiang, CN
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3013250653 MASIMO CORPORATION Irvine, CA, US
3013418500 Quintana Supply, a division of Thomas Scientific Haverhill, MA, US
9614470 RADIOMETER BASEL AG BASEL Basel-Stadt, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008595074. Last updated year: 2026. Please use registration number 3008595074 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.