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, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K823904
Device Name MODEL 515 NEO-TRAK NEONATAL MONITOR
Applicant
Ge Medical Systems Information Technologies
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ge Medical Systems Information Technologies
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/28/1982
Decision Date 05/25/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-