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, Non-Direct Patient Interface (Home-Use)
510(k) Number K871661
Device Name WH150 ROOM HUMIDIFIER
Applicant
Associated Mills, Inc.
165 N. Canal St.
Chicago,  IL  60606
Applicant Contact JOHN JIAMBALVO
Correspondent
Associated Mills, Inc.
165 N. Canal St.
Chicago,  IL  60606
Correspondent Contact JOHN JIAMBALVO
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received04/28/1987
Decision Date 06/15/1987
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
-
-