FDA-Device2018-05-09Class II
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
IntroMedic Co., Ltd.
Hazard
When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.
Sold states
Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
Affected count
82
Manufactured in
F-Rtek 6 Floor, 11-25 Simindaero327beon-Gil; Dongan, Anyang, N/A, Korea (the Republic of)
Products
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1615-2018Don't want to check this manually?
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