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, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K071606
Device Name BIOSIGN CENTRAL STATION
Applicant
Obs Medical
12900 N. Meridian St. Suite 120
Carmel,  IN  46032
Applicant Contact WAYNE NETHERCUTT
Correspondent
Obs Medical
12900 N. Meridian St. Suite 120
Carmel,  IN  46032
Correspondent Contact WAYNE NETHERCUTT
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/12/2007
Decision Date 08/31/2007
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
-
-