FDA 510(k) Application Details - DEN230027

Device Classification Name

  More FDA Info for this Device
510(K) Number DEN230027
Device Name NaviCam ProScan
Applicant Ankon Technologies Co., Ltd
B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road,
East Lake New, Technology Development Zone
Wuhan 430075 CN
Other 510(k) Applications for this Company
Contact Feng Wang
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code QZF
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/14/2023
Decision Date 12/12/2023
Decision DENG -
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review

FDA Source Information for DEN230027


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact