Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wireless Audio System

K-Number: K173409 · 2018-02-16

ApplicantNeocoil, LLC
Decision Date2018-02-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Audio System is a medical device manufactured by Neocoil, LLC. It received FDA 510(k) clearance on 2018-02-16 under approval number K173409. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless Audio System?

Wireless Audio System is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by Neocoil, LLC. The 510(k) number is K173409.

When was Wireless Audio System approved by the FDA?

Wireless Audio System received FDA 510(k) clearance on 2018-02-16, under approval number K173409.

What company makes Wireless Audio System?

Wireless Audio System is manufactured by Neocoil, LLC.

What is the FDA product code for Wireless Audio System?

The FDA product code for Wireless Audio System is LNH.

Related Clinical Trials

NCT07262827 Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT07603752 Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study RECRUITING NCT04956354 The Use of Wireless Sensors in Neonatal Intensive Care ACTIVE_NOT_RECRUITING NCT06693817 Advanced Wireless Sensors for Neonatal Care in the Delivery Room RECRUITING NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Neocoil, LLC

K160350ECG CT Gating Device K1733773.0T 16ch Breast Coil K1829581.5T 16ch Breast Coil K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch

View all 8 devices →

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑