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 Chamber, Patient Isolation
510(k) Number K022260
Device Name FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
Applicant
Isolation Systems, Inc.
79 Fillmore Ave.
Tonawanda,  NY  14150
Applicant Contact TED ULATOWSKI
Correspondent
Isolation Systems, Inc.
79 Fillmore Ave.
Tonawanda,  NY  14150
Correspondent Contact TED ULATOWSKI
Regulation Number880.5450
Classification Product Code
LGM  
Date Received06/28/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-