FDA.reportPublic FDA data

Foot switch

Primary DI
04260493313476
Brand
Foot switch
Company
Compumedics Germany GmbH
Model
Foot_switch_7910
Catalog number
7910
Device description
Foot switch USB, 2 functions
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051085000DOPPLER-BOXCompumedics Germany Gmgh2005-05-05IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260493313476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260493313476042604933134764260493313476

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888 757 5351info@dwl.de
+497731797690info@dwl.de

Regulatory Flags#

DUNS number
344791632
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260493312196DiaMon FixationFIx_DiaMon_789478942023-06-26
04260493310901LAM Fixation StandardFix_LAM_S_380638062020-12-09
04260493310987LAM Fixation MandibulaFix_LAM_M_399339932020-12-09
04260493311007LAM Fixation NeurosurgeryFix_LAM_N_399739972020-12-09
04260493311014LAM Fixation Carotid surgeryFix_LAM_C_399839982020-12-09
04260493311045Headband Fixation L/XLFix_Headband_L-XL_403840382020-12-09
04260493311052Headband Fixation L/XLFix_Headband_L-XL_403940392020-12-09
04260493311069Headband Fixation L/XLFix_Headband_L-XL_404040402020-12-09
04260493311076Headband Fixation L/XLFix_Headband_L-XL_404140412020-12-09
04260493311083Headband Fixation L/XLFix_Headband_L-XL_404240422020-12-09
04260493311137Headband Fixation XS/S/MFix_Headband_XS-S-M_553855382020-12-09
04260493311151Headband Fixation XS/S/MFix_Headband_XS-S-M_554055402020-12-09
04260493311175Headband Fixation XS/S/MFix_Headband_XS-S-M_554255422020-12-09
04260493311199Headband Fixation XS/S/MFix_Headband_XS-S-M_554455442020-12-09
04260493311205Headband Fixation XS/S/MFix_Headband_XS-S-M_554555452020-12-09
04260493311212LAM FixationFix_LAM_590559052020-12-09
04260493311243Headband Fixation XS/S/MFix_Headband_XS-S-M_678767872020-12-09
04260493311403LAM Fixation NeurosurgeryFix_LAM_N_686168612020-12-09
04260493311410LAM Fixation NeurosurgeryFix_LAM_N_686368632020-12-09
04260493311427LAM Fixation NeurosurgeryFix_LAM_N_686568652020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
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08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
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00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27