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 Aid, Cardiopulmonary Resuscitation
510(k) Number K183348
Device Name Reusable Silicone Cover CPRmeter 2
Applicant
Laerdal Medical AS
Tanke Svilandsgate 30
Stavanger,  NO 2007
Applicant Contact Mari Kaada
Correspondent
MED Institute Inc.
1330 Win Hentschel Blvd.
West Lafayette,  IN  47906
Correspondent Contact Dan Dillon
Regulation Number870.5210
Classification Product Code
LIX  
Date Received12/03/2018
Decision Date 12/17/2018
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
-
-