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 Ventilator, Continuous, Facility Use
510(k) Number K011957
Device Name IVENT 201 PORTABLE VENTILATOR
Applicant
Versamed , Ltd.
Atidim Industrial Park, Bldg. 2
P.O. Box 58135
Tel-Aviv,  IL 61580
Applicant Contact KEN RAICHMAN
Correspondent
Versamed , Ltd.
Atidim Industrial Park, Bldg. 2
P.O. Box 58135
Tel-Aviv,  IL 61580
Correspondent Contact KEN RAICHMAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/22/2001
Decision Date 07/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-