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 K012085
Device Name SOMNO STAR & SERIES SLEEP SYSTEM
Applicant
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact LINDA MURDOCK
Correspondent
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact LINDA MURDOCK
Regulation Number882.1400
Classification Product Code
OLV  
Date Received07/03/2001
Decision Date 08/02/2001
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
-
-