FDA-Device2021-06-30Class II
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Exact Medical Manufacturing, Inc.
Hazard
No 510k for the product to be used in a natural or surgical opening to the body
Sold states
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Affected count
100600 units
Manufactured in
4917 William St Ste C, N/A, Lancaster, NY, United States
Products
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1915-2021Don't want to check this manually?
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