FDA.reportPublic FDA data

ATMOS

Primary DI
04250365167832
Brand
ATMOS
Company
ATMOS MedizinTechnik GmbH & Co. KG
Model
Strobo 21 LED (integrated in ATMOS S 61 Servant)
Device description
The device is intended to record and analyze frequency and sound pressure level of a voice. It can trigger a light source accordingly. The device allows a phase shift adjustment and pulse width regulation for the illumination.
Published
2024-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
EQLLaryngostroboscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQLLaryngostroboscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250365167832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250365167832042503651678324250365167832

GMDN Terms#

Term, Definition table
TermDefinition
LaryngostroboscopeA device that is intended to allow the observation of glottic action during phonation (speech) in the examination of voice disorders. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. It can contain a microphone that captures the acoustic signals from the glottic area and may or may not contact the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
319591939
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250365195071ATMOSC 051 Thorax2025-03-25
04250365142273ATMOSVariotherm plus2024-11-27
04250365142297ATMOSHygrotherm plus2024-11-27
04250365143065ATMOSVarioair2024-11-27
04250365149791ATMOSC 21 Economy - function column (230 V~)2024-11-27
04250365149807ATMOSC 21 Economy - function column (115 V~)2024-11-27
04250365149814ATMOSC 21 Economy - function column (127 V~)2024-11-27
04250365149821ATMOSC 31 Economy - function column (230 V~)2024-11-27
04250365149838ATMOSC 31 Economy - function column (115 V~)2024-11-27
04250365149845ATMOSC 31 Economy - function column (127 V~)2024-11-27
04250365155471ATMOSHL 21 LED2024-11-27
04250365155488ATMOSHL 21 LED (examination set)2024-11-27
04250365155495ATMOSHL 21 LED (OT set)2024-11-27
04250365155839ATMOSLS 21 LED2024-11-27
04250365155860ATMOSLS 21 LED set, white2024-11-27
04250365156034ATMOSStrobo 21 LED2024-11-27
04250365164084ATMOSS 61 Servant ENT workstation (230 V~)2024-11-27
04250365164107ATMOSS 61 Servant ENT workstation (115 V~)2024-11-27
04250365164114ATMOSS 61 Servant ENT workstation (127 V~)2024-11-27
04250365166187ATMOSS 61 Servant Vision2024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333255733PENTAX Medical Laryngeal StroboscopePENTAX OF AMERICA, INC.EQL2025-10-06
04961333255740PENTAX Medical Rigid LaryngostroboscopesPENTAX OF AMERICA, INC.EQL2025-10-03
04961333255016LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04961333255702LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04961333255719LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04961333255726LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04048551327074NAKarl Storz GmbH & Co. KGEQL2025-03-28
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04250365156034ATMOSATMOS MedizinTechnik GmbH & Co. KGEQL2024-11-27
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EQL2024-11-14
08436041580256OptomicOPTOMIC ESPAÑA SAEQL2024-07-17
08436041580263OptomicOPTOMIC ESPAÑA SAEQL2024-07-17
00848657070218LaryngostroboscopeNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EQL2023-10-12
04961333128174PENTAXHOYA CORPORATIONEQL2023-07-31
04042761069663OlympusOLYMPUS Winter & Ibe GmbHEQL2023-06-20
04042761069670OlympusOLYMPUS Winter & Ibe GmbHEQL2023-06-20
04580137730279MACHIDAMACHIDA ENDOSCOPE CO.,LTD.EQL2023-06-09
M6334949910JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-05-09
04961333253890PENTAX MedicalHOYA CORPORATIONEQL2023-03-13
M6337064050JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640510JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640520JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640710JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640720JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640730JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640740JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07