• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name oximeter
510(k) Number K921454
Device Name FUKUDA DENSHI MODEL HG-301
Original Applicant
FUKUDA DENSHI USA, INC.
7102-a 180th avenue northeast
redmond,  WA  98052
Original Contact robert steurer
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/26/1992
Decision Date 04/01/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-