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 Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K880979
Device Name MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
Applicant
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Applicant Contact JOHN G ADAMS
Correspondent
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Correspondent Contact JOHN G ADAMS
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/08/1988
Decision Date 07/15/1988
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
-
-