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 K863154
Device Name HEATED JET HUMIDIFIER MODEL AMS-1020
Applicant
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Applicant Contact AJAI SINGH
Correspondent
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Correspondent Contact AJAI SINGH
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/15/1986
Decision Date 01/12/1987
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
-
-