The following data is part of a premarket notification filed by Navifus Corporation with the FDA for Navirfa Scope.
|Device Name:||NAVIRFA Scope|
|Classification||System, Imaging, Pulsed Echo, Ultrasonic|
|Applicant||NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City, TW 10367|
NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City, TW 10367
|CFR Regulation Number||892.1560 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|