FDA.reportPublic FDA data

MRIaudio

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146807163014680716MRIAUDIO, INC.1N2026-01-015909 SEA LION PL STE F Carlsbad CA US 92010

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B6693301MRIaudio Over-Ear Headphones - MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection.8584270679support@mriaudio.com
B669SMNS00011MRIaudio Siemens System - MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system.8584270679support@mriaudio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2188441965461501K193102MRIaudio PREM System with MRIviewLNH2020-01-06
2188441475508908K180100MRIaudio PREM SystemLNH2018-06-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH22020-01-06

PMN#

GUDID#