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510(k) K190760

Device
Cadwell Bolt Software
Applicant
Cadwell Industries, Inc.
510(k) number
K190760
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-23
Date received
2019-03-25
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Emily Whitehead
Address
909 N Kellogg St. Kennewick WA US 99336 99336

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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