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 Monitor, Bed Patient
510(k) Number K914859
Device Name BARTRONIX IN-BED ACTIVITY MONITOR
Applicant
Bartronix
7304 Bristlecone Ct.
Fort Worth,  TX  76137
Applicant Contact IRTA HUDGINS
Correspondent
Bartronix
7304 Bristlecone Ct.
Fort Worth,  TX  76137
Correspondent Contact IRTA HUDGINS
Regulation Number880.2400
Classification Product Code
KMI  
Date Received10/29/1991
Decision Date 04/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-