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 K874597
Device Name THERMOVENT 600, 1200, T, 02
Applicant
PORTEX, INC.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact EDWIN G GROVE
Correspondent
PORTEX, INC.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact EDWIN G GROVE
Regulation Number868.5375
Classification Product Code
BYD  
Date Received11/09/1987
Decision Date 01/19/1988
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
Recalls CDRH Recalls
-
-