FDA.reportPublic FDA data

LEVO

Primary DI
B400215720
Brand
LEVO
Company
OTOHARMONICS CORPORATION
Model
MANAGER
Published
2018-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140845000LEVO TINNITUS MASKING SOFTWARE DEVICEOtoharmonics Corp2014-07-18KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B400215720PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus masking application softwareAn individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format to enable it to provide generated noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). The basic set of applications programs and routines can be upgraded to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078763400
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B400215930LEVOPATIENT2018-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SKLW2026-10-05
05708296394036BeltoneGn Hearing A/SKLW2026-10-05
05708296394098BeltoneGn Hearing A/SKLW2026-10-05
05708296394104BeltoneGn Hearing A/SKLW2026-10-05
05708296394111BeltoneGn Hearing A/SKLW2026-10-05
05708296394128BeltoneGn Hearing A/SKLW2026-10-05
05708296394135BeltoneGn Hearing A/SKLW2026-10-05
05708296394197BeltoneGn Hearing A/SKLW2026-10-05
05708296394203BeltoneGn Hearing A/SKLW2026-10-05
05708296394210BeltoneGn Hearing A/SKLW2026-10-05
05708296394487BeltoneGn Hearing A/SKLW2026-10-05
05708296394494BeltoneGn Hearing A/SKLW2026-10-05
05708296394555BeltoneGn Hearing A/SKLW2026-10-05
05708296394562BeltoneGn Hearing A/SKLW2026-10-05
05708296394579BeltoneGn Hearing A/SKLW2026-10-05
05708296394586BeltoneGn Hearing A/SKLW2026-10-05
05708296394593BeltoneGn Hearing A/SKLW2026-10-05
05708296394654BeltoneGn Hearing A/SKLW2026-10-05
05708296394661BeltoneGn Hearing A/SKLW2026-10-05
05708296394678BeltoneGn Hearing A/SKLW2026-10-05
05708296397877BeltoneGn Hearing A/SKLW2026-10-05
05708296397884BeltoneGn Hearing A/SKLW2026-10-05
05708296397945BeltoneGn Hearing A/SKLW2026-10-05
05708296397952BeltoneGn Hearing A/SKLW2026-10-05
05708296397969BeltoneGn Hearing A/SKLW2026-10-05
05708296429455BeltoneGn Hearing A/SKLW2026-10-05
05708296429462BeltoneGn Hearing A/SKLW2026-10-05
05708296429523BeltoneGn Hearing A/SKLW2026-10-05
05708296429530BeltoneGn Hearing A/SKLW2026-10-05
05708296429547BeltoneGn Hearing A/SKLW2026-10-05