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 oximeter
510(k) Number K190399
Device Name Beddr 200 System
Applicant
Hancock Medical, Inc.
897 Independence Avenue, #3A
mountain view,  CA  94043
Applicant Contact tom goff
Correspondent
Hancock Medical, Inc.
897 Independence Avenue, #3A
mountain view,  CA  94043
Correspondent Contact tom goff
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/19/2019
Decision Date 08/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-