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 amplifier, physiological signal
510(k) Number K230148
Device Name Vlab
Applicant
DormoTech Medical Ltd.
Yitzhak Rabin 21
Afula,  IL 33704
Applicant Contact Abed Nassir
Correspondent
ProMedic Consulting LLC
131 Bay Point Dr NE
Saint Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
MNR  
Date Received01/19/2023
Decision Date 10/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-