• 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 ventilator, continuous, facility use
510(k) Number K120574
Device Name HAMILTON-C1
Applicant
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH CH-7402
Applicant Contact RALPH AGUILA
Correspondent
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH CH-7402
Correspondent Contact RALPH AGUILA
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/27/2012
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-