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 Amplifier, Physiological Signal
510(k) Number K904222
Device Name VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Applicant Contact LARRY WOODARD
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Correspondent Contact LARRY WOODARD
Regulation Number882.1835
Classification Product Code
GWL  
Date Received09/13/1990
Decision Date 01/18/1991
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
-
-