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 Automatic Event Detection Software For Polysomnograph With Electroencephalograph
510(k) Number K890513
Device Name SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
Applicant
Micro Tronics Corp.
P.O. Box 399
Carrboro,  NC  27510
Applicant Contact JACK R SMITH
Correspondent
Micro Tronics Corp.
P.O. Box 399
Carrboro,  NC  27510
Correspondent Contact JACK R SMITH
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received02/01/1989
Decision Date 04/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-