• 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 K014025
Device Name HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
Applicant
HOMMED LLC.
2018 NORTH DURHAM DR.
HOUSTON,  TX  77008
Applicant Contact TOMMIE J MORGAN
Correspondent
HOMMED LLC.
2018 NORTH DURHAM DR.
HOUSTON,  TX  77008
Correspondent Contact TOMMIE J MORGAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/06/2001
Decision Date 04/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-