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FDA Clearances K160880, K150336, K180338, and K202361
FDA Good Manufacturing Practices
ISO 13485:2016
ISO 14971:2007
ISO/IEC 17025:2005
IEC 60601-1:2012
IEC 60601-1-2:2007
IEC 60601-2-57:2011
IEC 62471:2006
ANSI/AAMI ES60601-1:2005/(R) 2012
ISTA 3A Shipping & Handling (ASTM)
Toxikon Animal Testing 14-00947-N1
ClinicalTrials.gov NCT02867150, NCT03647748, NCT04525573, and NCT04524715
Devices and services U.S. Patents 9,044,595, 9,498,641, 9,808,314, 10,946,210, and 63/074,790

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