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 Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K230459
Device Name C.C. Life 21
Applicant
21 Equipment S.R.L.
Piazza Bodoni 3
Torino,  IT 10123
Applicant Contact Dolores Moretto
Correspondent
21 Equipment S.R.L.
Piazza Bodoni 3
Torino,  IT 10123
Correspondent Contact Dolores Moretto
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/21/2023
Decision Date 10/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-