• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K211777
Device Name ARCO FP-S
A.T.S. Applicazione Tecnologie Speciali S.R.L.
Via Alessandro Volta, 10
Torre De Roveri,  IT 24060
Applicant Contact Livia Pillitteri
Kamm & Associates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
Subsequent Product Code
Date Received06/09/2021
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No