• 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 System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K993938
Device Name THE HOMMED SENTRY, MODEL 1 SENTRY
Applicant
Hommed, LLC
19275 W. Capitol Dr.
Suite 200
Brookfield,  WI  53045
Applicant Contact HERSCHEL PEDDICORD
Correspondent
Hommed, LLC
19275 W. Capitol Dr.
Suite 200
Brookfield,  WI  53045
Correspondent Contact HERSCHEL PEDDICORD
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/19/1999
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-