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 K002622
Device Name BIOSLEEP
Applicant
OXFORD BIOSIGNALS LIMITED
OXFORD SCIENCE PARK
OXFORD, OX4 4 GA,  GB OX4 4
Applicant Contact PAULINE A HOBDAY
Correspondent
OXFORD BIOSIGNALS LIMITED
OXFORD SCIENCE PARK
OXFORD, OX4 4 GA,  GB OX4 4
Correspondent Contact PAULINE A HOBDAY
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received08/23/2000
Decision Date 10/23/2000
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
-
-