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 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K080141
Device Name PC ECG 1200W SYSTEM
Applicant
Norav Medical , Ltd.
Industrial Park 13,
M.P. Misgav
Mitzpe Aviv,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Norav Medical , Ltd.
Industrial Park 13,
M.P. Misgav
Mitzpe Aviv,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/22/2008
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-