FDA 510(k), K210162, Endoscope Model EI-740D/S

FDA 510(k), K210162, Endoscope Model EI-740D/S

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510(K) Number: K210162
Device Name: Endoscope Model EI-740D/S
Manufacturer: Randy Vader
Device Classification Name: Gastroscope And Accessories, Flexible/Rigid
Regulation Number: FDS
Classification Product Code: KXA
Date Received: 01/21/2021
Decision Date: 04/09/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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