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 Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
510(k) Number K853734
Device Name APOLLO DENSITOMETER
Applicant
Astral Medical Systems
2861 Pullman St.
Santa Ana,  CA  92705
Applicant Contact KEITH S FAIRCHILD
Correspondent
Astral Medical Systems
2861 Pullman St.
Santa Ana,  CA  92705
Correspondent Contact KEITH S FAIRCHILD
Regulation Number862.2400
Classification Product Code
JQT  
Date Received09/06/1985
Decision Date 09/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-