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 Standard Polysomnograph With Electroencephalograph
510(k) Number K992291
Device Name H20- TETHERED OPTION
Applicant
Grass-Telefactor Product Group
1094 New Dehaven Ave.
West Conshohocken,  PA  19428
Applicant Contact JAMES S BRYAN
Correspondent
Grass-Telefactor Product Group
1094 New Dehaven Ave.
West Conshohocken,  PA  19428
Correspondent Contact JAMES S BRYAN
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received07/07/1999
Decision Date 08/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-