510(k) K853734

APOLLO DENSITOMETER by Astral Medical Systems — Product Code JQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1985
Date Received
September 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class
Class I
Regulation Number
862.2400
Review Panel
CH
Submission Type