MRIAUDIO, INC.

Address:5909 SEA LION PL STE F,Carlsbad,CA,92010,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Nuclear Magnetic Resonance Imaging (LNH) (5)

Premarket Exempt

Clear

Wishbone Headset - B6693201 Catalog Number : 320

Device Description : MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB hearing protection and allows patients to listen to audio entertainment. Standard two prong pneumatic headphone connection. Designed for use with MRIaudio Ear-tips.

Device Class : 2

Duns Number: 026681280

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

MRIaudio Over-Ear Headphones - B6693301 Catalog Number : 330

Device Description : MRI-safe ear defenders provide patients with 29dB of hearing protection and allo 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.

Device Class : 2

Duns Number: 026681280

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

MRIaudioPREM1000 with MRIview - B66935001 Catalog Number : 3500

Device Description : The MRIaudio PREM system with MRIview is an MRI conditional audio and video solu The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.

Device Class : 2

Duns Number: 026681280

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

MRIaudioPREM1001 with MRIview - B66935011 Catalog Number : 3501

Device Class : 2

Duns Number: 026681280

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

MRIaudio Siemens System - B669SMNS00011 Catalog Number : SMNS0001

Device Description : MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system.

Device Class : 2

Duns Number: 026681280

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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