510(k) K813490

VERSION OF A CLOSED-FLOW SYS. CALORIC by Thomas M. Foti, M.D. — Product Code ETF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1982
Date Received
December 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type