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510(k) K864494

MODEL 6500 OPTHALMIC CHAIR by Koken Mfg Company, Inc. — Product Code HME

K864494 is an FDA 510(k) premarket notification submitted by Koken Mfg Company, Inc. for the device "MODEL 6500 OPTHALMIC CHAIR". The FDA issued a decision of Substantially Equivalent on December 15, 1986. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. Koken Mfg Company, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1986
Date Received
November 14, 1986
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 Koken Mfg Company, Inc.

  • K864501 — KOKEN'S NEW MODEL M-3000 POWER TABLE (December 16, 1986)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K864295 — DR.500O OPERATING TABLE (November 19, 1986)
  • K864325 — DR7700 OPERATING TABLE (November 19, 1986)

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)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K863728 — THE ERGOSYSTEM CHAIR (October 31, 1986)
  • K863008 — -OM WEST 2000 GNATUS CHAIR (September 24, 1986)
  • K853743 — TECHNA VISION, INC. ELECTRIC CHAIR (October 17, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)
  • K853150 — RELIANCE 6100 (September 5, 1985)

FDA data resources