510(k) K821107

EXOPHTHALMOMETER by Medical Equipment Designs, Inc. — Product Code HCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
April 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Temperature Measurement, Direct Contact, Powered
Device Class
Class II
Regulation Number
882.1570
Review Panel
NE
Submission Type