FDA.reportPublic FDA data

Faros

Primary DI
06430035220175
Brand
Faros
Company
Bittium Biosignals Oy
Model
Faros 360
Device description
Device for 3-channel ECG and motion measurement, monitoring and data collection
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143032000eMotion Faros ECG MobileMega Electronics , Ltd.2015-03-29DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035220175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035220175064300352201756430035220175

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel electrocardiograph, signal-averagingAn instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously to simplify and facilitate interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It is noninterpretive and reduces signal noise level by performing an average of multiple cycles of the signal; it may be used to detect late potentials for the identification of patients prone to ventricular tachycardia.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358175817700mega@megaemg.com

Regulatory Flags#

DUNS number
369960000
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035220311Faros 360 waterproofFaros 3609011592018-04-30
06430035220014FemiScanHTCS-22016-09-22
06430035220021FemiScanCover2016-09-22
06430035220199ME6000ME6000 4ch2016-09-22
06430035220205ME6000ME6000 8ch2016-09-22
06430035220212ME6000ME6000 16ch2016-09-22
06430035220236ME6000ME6000 4ch WLAN2016-09-22
06430035220243ME6000ME6000 8ch WLAN2016-09-22
06430035220229eMotion ECGeMotion ECG sensor2016-09-22
06430035220328Bittium Faros 180 waterproofFaros 1802021-12-17
06430035220519Bittium OmegaSnap 1-CH ECG Electrode9404644 2021-12-17
06430035220588Bittium OmegaSnap 1-CH Adapter94001472021-12-17
06430035220670Bittium OmegaSnap 2-CH ECG Electrode94047162021-12-17
06430035220687Bittium OmegaSnap 3-CH ECG Electrode94047172021-12-17
06430035220694Bittium OmegaSnap 1-CH ECG Electrode 94047182021-12-17
06430035220700Bittium OmegaSnap Multi-CH Adapter94047192021-12-17
06430035220151FarosFaros 902016-09-22
06430035220168FarosFaros 1802016-09-22
06430035220366Bittium FarosFaros 14d2019-10-23
06430035220335Fast-Fix ECG Electrode9011552018-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVue Lifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23
B210AC0110KardiaBand SystemAlivecor, Inc.DXH2024-03-22
03700546708275Withings®WITHINGSDXH2023-09-07
03700546708435Withings®WITHINGSDXH2023-08-30
03700546708442Withings®WITHINGSDXH2023-08-30