510(k) K915340

MENTOR HORIZON LOW VISION MAGNIFIER by Mentor O & O, Inc. — Product Code HJG

K915340 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MENTOR HORIZON LOW VISION MAGNIFIER". The FDA issued a decision of Substantially Equivalent on March 30, 1992. The device falls under product code HJG (System, Reading, Television, Closed-Circuit), a Class I device regulated under 21 CFR 886.5820. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1992
Date Received
October 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Reading, Television, Closed-Circuit
Device Class
Class I
Regulation Number
886.5820
Review Panel
OP
Submission Type