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, Non-Continuous (Respirator)
510(k) Number K861555
Device Name CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
Applicant
Respiratory Care, Inc.
900 W. University
Arlington Heights,  IL  60004
Applicant Contact WILKE
Correspondent
Respiratory Care, Inc.
900 W. University
Arlington Heights,  IL  60004
Correspondent Contact WILKE
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/25/1986
Decision Date 06/05/1986
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
-
-