510(k) K761308

ELECTRONIC STETHOSCOPE by Medline Industries, Inc. — Product Code DPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1977
Date Received
December 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type