DEVICE: eMotion ECG (06430035220229)
Device Identifier (DI) Information
eMotion ECG
eMotion ECG sensor
Not in Commercial Distribution
Bittium Biosignals Oy
eMotion ECG sensor
Not in Commercial Distribution
Bittium Biosignals Oy
Device for 1-channel ECG monitoring
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
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11413 | Electrocardiograph, professional, single-channel |
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K131699 | 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
21629256-43fa-49b2-ac09-21bb847f7965
December 31, 2021
8
September 22, 2016
December 31, 2021
8
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
bbs@bittium.com
bbs@bittium.com