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 Tent, Oxygen
510(k) Number K935126
Device Name NASCOR IGLOO
Applicant
Nascor Pty. , Ltd.
P.O. Box 141 Beverly Hills Nsw
Sydney Nsw,  AU 2209
Applicant Contact HOWARD CHILTON, M.D.
Correspondent
Nascor Pty. , Ltd.
P.O. Box 141 Beverly Hills Nsw
Sydney Nsw,  AU 2209
Correspondent Contact HOWARD CHILTON, M.D.
Regulation Number868.5700
Classification Product Code
BYL  
Date Received10/28/1993
Decision Date 10/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-