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 Aspirator, Endocervical
510(k) Number K902954
FOIA Releasable 510(k) K902954
Device Name OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
Applicant
Permobil AB
30 Ray Ave.
Burlington,  MA  01803
Applicant Contact FINKELSTEIN, MD
Correspondent
Permobil AB
30 Ray Ave.
Burlington,  MA  01803
Correspondent Contact FINKELSTEIN, MD
Regulation Number884.1050
Classification Product Code
HFC  
Date Received07/05/1990
Decision Date 08/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-