• 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 electrode, cutaneous
510(k) Number K032278
Device Name AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
linthicum,  MD  21090 -1356
Applicant Contact sanjay parikh
Correspondent
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
linthicum,  MD  21090 -1356
Correspondent Contact sanjay parikh
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/24/2003
Decision Date 03/05/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-