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510(k) K853743

TECHNA VISION, INC. ELECTRIC CHAIR by Techna Vision — Product Code HME

K853743 is an FDA 510(k) premarket notification submitted by Techna Vision for the device "TECHNA VISION, INC. ELECTRIC CHAIR". The FDA issued a decision of Substantially Equivalent on October 17, 1985. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. 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
Chair, Ophthalmic, Ac-Powered
Device Class
Class I
Regulation Number
886.1140
Review Panel
OP
Submission Type

Other clearances by Techna Vision

  • K862578 — TECHNA VISION CASTING RESIN (July 23, 1986)
  • K853290 — TECHNA VISION AUTO-PERIMETER (November 12, 1985)
  • K853744 — TECHNA VISION, INC.ELECTRIC TABLE (October 17, 1985)

Other clearances for product code HME

  • K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (July 6, 1993)
  • K914416 — BREATH-EASY, MODIFICATION (June 23, 1992)
  • K894018 — RELIANCE(R) 6200 EXAMINATION CHAIR (September 12, 1989)
  • K870112 — STORZ ENT/OPHTHALMIC MAXI CHAIR (February 12, 1987)
  • K864494 — MODEL 6500 OPTHALMIC CHAIR (December 15, 1986)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K863728 — THE ERGOSYSTEM CHAIR (October 31, 1986)
  • K863008 — -OM WEST 2000 GNATUS CHAIR (September 24, 1986)
  • K853151 — RELIANCE 5000 (September 5, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)

FDA data resources