510(k) K781014

AUTOREFRACTOR, SUBJECTIVE by Cavitron Corp. — Product Code HKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1978
Date Received
June 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type