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 Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K944194
Device Name DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
Applicant
Med-Tek Innovations, Inc.
1223 S. 23 St.
Milwaukee,  WI  53204
Applicant Contact ALAN WHITMARSH
Correspondent
Med-Tek Innovations, Inc.
1223 S. 23 St.
Milwaukee,  WI  53204
Correspondent Contact ALAN WHITMARSH
Regulation Number868.5375
Classification Product Code
BYD  
Date Received08/29/1994
Decision Date 09/13/1994
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
-
-