FDA-Device2020-04-08Class II
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
Butterfly Network, Inc.
Hazard
Distributed without an approved 510(k)
Sold states
US Nationwide distribution.
Affected count
11,183
Manufactured in
530 Old Whitfield St, N/A, Guilford, CT, United States
Products
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1601-2020Don't want to check this manually?
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