FDA-Device2019-10-30Class II
The ICS CHARTR EP 200
GN Otometrics
Hazard
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Sold states
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guyana, Hong Kong, Hungary, India, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Malaysia, Maldives, Mayotte, Mexico, Morocco, Morocco, Netherlands, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam, and Zimbabwe
Affected count
3071 individual units
Manufactured in
Horskatten 9, Taastrup, Denmark
Products
The ICS CHARTR EP 200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0170-2020Don't want to check this manually?
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