DEVICE: Alpine BioMed (05704736017220)
Device Identifier (DI) Information
Alpine BioMed
9033A0721HA
Not in Commercial Distribution
Alpine Biomed ApS
9033A0721HA
Not in Commercial Distribution
Alpine Biomed ApS
"Keypoint Focus Workstation, Intl. 115V (ENG)
Including:
- USFF PC with Keypoint software, 22” display
- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators
- Cart with isolating power supply
- System kit"
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
11474 | Electromyograph |
An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWF | Stimulator, Electrical, Evoked Response |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K944547 | 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
4ae93e25-2184-4c1b-85cd-4c019c95bf8c
November 28, 2022
5
August 24, 2016
November 28, 2022
5
August 24, 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
[?]
No Customer Contact currently defined