• 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 K052615
Device Name MEDISIZE GOLD
Applicant
MEDISIZE BV
EDISONSTRAAT 1
HILLEGOM,  NL 2180 AB
Applicant Contact SOPIHA LAM
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact J.A. VAN VUGT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/23/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-