510(k) K851745

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B by Artiberia — Product Code ERA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type