• 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
510(k) Number K921846
Device Name OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC
Applicant
Oceania Health Care Systems, Inc.
325 Lytton Ave.
Suite 400
Palo Alto,  CA  94302
Applicant Contact RICHARD M PETERS
Correspondent
Oceania Health Care Systems, Inc.
325 Lytton Ave.
Suite 400
Palo Alto,  CA  94302
Correspondent Contact RICHARD M PETERS
Classification Product Code
LNX
Date Received04/17/1992
Decision Date 08/08/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-