FDA-Device2020-02-12Class II
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
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
4
Manufactured in
212 Avenida Fabricante, N/A, San Clemente, CA, United States
Products
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2020Don't want to check this manually?
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