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 system, tomography, computed, emission
510(k) Number K971980
Device Name MCD-AC
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact DENNIS W HENKELMAN
Correspondent
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Correspondent Contact DENNIS W HENKELMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/29/1997
Decision Date 10/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-