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FDA 510(k), K180711, FUJIFILM Endoscopic CO2 Regulator GW-100
FDA 510(k), K180711, FUJIFILM Endoscopic CO2 Regulator GW-100
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510(K) Number: K180711
Device Name: FUJIFILM Endoscopic CO2 Regulator GW-100
Manufacturer: Randy Vader
Device Classification Name: Insufflator, Automatic Carbon-Dioxide For Endoscope
Regulation Number: FCX
Classification Product Code: KXA
Date Received: 03/19/2018
Decision Date: 05/25/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: FUJIFILM Endoscopic CO2 Regulator GW-100
Manufacturer: Randy Vader
Device Classification Name: Insufflator, Automatic Carbon-Dioxide For Endoscope
Regulation Number: FCX
Classification Product Code: KXA
Date Received: 03/19/2018
Decision Date: 05/25/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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