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 K933597
Device Name AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH
Applicant
ARTHRO-MEDIC, INC.
RISSNELEDEN 136
S-172 48 SUNDBYBERT
SWEDEN,  SE
Applicant Contact CAROL HAMILTON
Correspondent
ARTHRO-MEDIC, INC.
RISSNELEDEN 136
S-172 48 SUNDBYBERT
SWEDEN,  SE
Correspondent Contact CAROL HAMILTON
Regulation Number868.5375
Classification Product Code
BYD  
Subsequent Product Code
CAH  
Date Received07/26/1993
Decision Date 11/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-