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 K993268
Device Name MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
Applicant
MALLINCKRODT DAR S.R.L.
VIA G.BOVE, 2/4/6/8
MIRANDOLA (MODENA),  IT 41037
Applicant Contact GIUSEPPE TOMASINI
Correspondent
MALLINCKRODT DAR S.R.L.
VIA G.BOVE, 2/4/6/8
MIRANDOLA (MODENA),  IT 41037
Correspondent Contact GIUSEPPE TOMASINI
Regulation Number868.5450
Classification Product Code
BTT  
Subsequent Product Code
CAI  
Date Received09/30/1999
Decision Date 04/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-