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, oxygen, cutaneous, for infant not under gas anesthesia
510(k) Number K861861
Device Name 515A NEO-TRAK NEONATAL MONITOR
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Applicant Contact JOSEPH P LENZEN
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Correspondent Contact JOSEPH P LENZEN
Regulation Number868.2500
Classification Product Code
KLK  
Date Received05/14/1986
Decision Date 07/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-