Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 massager, vacuum, radio frequency induced heat
510(k) Number K200359
Device Name NuEra Tight, NuEra Tight EMS
Applicant
Bios s.r.l.
Via Guido Rossa 10/12
Vimodrone,  IT 20090
Applicant Contact Maurizio Bianchi
Correspondent
Bios s.r.l.
Via Guido Rossa 10/12
Vimodrone,  IT 20090
Correspondent Contact Maurizio Bianchi
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
NGX  
Date Received02/13/2020
Decision Date 08/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-