510(k) K811180

ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ by American Optical Corp. — Product Code HOS

K811180 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code HOS (Projector, Ophthalmic), a Class I device regulated under 21 CFR 886.1680. American Optical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Projector, Ophthalmic
Device Class
Class I
Regulation Number
886.1680
Review Panel
OP
Submission Type