U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
VEST 6.6 or earlier software - Product Code LXV
원인
Marketed without a 510k or pma submission to include the normative data display.
조치
A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance.
Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.
Worldwide Distribution -- US (states of AL, AZ, CA, DC, FL, GA, HI, IN, MA, MD, MI, MN, NC, NY, OR, PA, SC, TN, UT, VA, WA, and WV), Korea, United Kingdom, and Spain.
제품 설명
VEST 6.6 or earlier software for use with Neuro Kinetics products. || The device is used for vestibular testing.