FDA.reportPublic FDA data

Oscilla

Primary DI
57135570000005
Brand
Oscilla
Company
Inmedico A/S
Model
SM950
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57135570000005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5713557000000557135570000005

GMDN Terms#

Term, Definition table
TermDefinition
Pure-tone audiometerAn electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal120 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal120 KiloPascal
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4586742622support@oscillahearing.com

Regulatory Flags#

DUNS number
305698078
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713557000014OscillaSM9102016-09-21
05713557000021OscillaSM910-B2016-09-21
05713557000038OscillaSM920-P2016-09-21
05713557000045OscillaSM9302016-09-21
05713557000052OscillaSM9502016-09-21
05713557000069OscillaSM950-S2016-09-21
05713557000076OscillaSM960-C2016-09-21
05713557000083OscillaSM450-FF2016-09-21
05713557000090OscillaUSB3102016-09-21
05713557000106OscillaUSB3302016-09-21
05713557000113OscillaUSB350-B2016-09-21
05713557000120OscillaUSB350-SP2016-09-21
57135570000025OscillaSM910-B2016-09-21
57135570000032OscillaSM920-P2016-09-21
57135570000049OscillaSM9302016-09-21
57135570000056OscillaSM9502016-09-21
57135570000063OscillaSM950-S2016-09-21
57135570000070OscillaSM960-C2016-09-21
57135570000087OscillaSM450-FF2016-09-21
57135570000094OscillaUSB3102016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245110Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245127Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
04260223147326nanoAudio DD45PATH medical GmbHEWO2025-08-05
04260223147333nanoAudio DD65v2PATH medical GmbHEWO2025-08-05
04260223147340nanoAudio Patient Response ButtonPATH medical GmbHEWO2025-08-05