DEVICE: Faros (06430035220175)
Device Identifier (DI) Information
Faros
Faros 360
In Commercial Distribution
Bittium Biosignals Oy
Faros 360
In Commercial Distribution
Bittium Biosignals Oy
Device for 3-channel ECG and motion measurement, monitoring and data collection
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17687 | Multichannel electrocardiograph, signal-averaging |
An 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.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K143032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7b18db29-4bfb-4f37-8a6b-3fe50eca286e
March 04, 2021
4
September 22, 2016
March 04, 2021
4
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+358175817700
mega@megaemg.com
mega@megaemg.com