510(k) K853744

TECHNA VISION, INC.ELECTRIC TABLE by Techna Vision — Product Code HRJ

K853744 is an FDA 510(k) premarket notification submitted by Techna Vision for the device "TECHNA VISION, INC.ELECTRIC TABLE". The FDA issued a decision of Substantially Equivalent on October 17, 1985. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Techna Vision has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1985
Date Received
September 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Instrument, Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.4855
Review Panel
OP
Submission Type