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 Accessory To Continuous Ventilator (Respirator)
510(k) Number K052244
Device Name IISIS, VERSION 1.0
Applicant
Innovision Medical Technologies, LLC
1302 Concourse Dr.
Suite 302
Linthicum,  MD  21090
Applicant Contact PATRICIA L ANDREWS
Correspondent
Innovision Medical Technologies, LLC
1302 Concourse Dr.
Suite 302
Linthicum,  MD  21090
Correspondent Contact PATRICIA L ANDREWS
Regulation Number868.5895
Classification Product Code
MOD  
Date Received08/17/2005
Decision Date 10/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-