DEVICE: Eko Core Attachment (00863609000310)
Device Identifier (DI) Information
Eko Core Attachment
Model E4
In Commercial Distribution
Eko Devices, Inc.
Model E4
In Commercial Distribution
Eko Devices, Inc.
The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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13754 | Electronic stethoscope |
An external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or display.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DQD | Stethoscope, Electronic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151319 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
14f0252c-57f8-4790-92e4-6d62e2c07083
June 10, 2022
5
September 26, 2016
June 10, 2022
5
September 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined