FDA-Device2020-02-12Class II
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Pacific Medical Group Inc.
Hazard
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Sold states
U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE
Affected count
678
Manufactured in
212 Avenida Fabricante, N/A, San Clemente, CA, United States
Products
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2020Don't want to check this manually?
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