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510(k) K894018

RELIANCE(R) 6200 EXAMINATION CHAIR by Reliance Medical Products, Inc. — Product Code HME

K894018 is an FDA 510(k) premarket notification submitted by Reliance Medical Products, Inc. for the device "RELIANCE(R) 6200 EXAMINATION CHAIR". The FDA issued a decision of Substantially Equivalent on September 12, 1989. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1989
Date Received
June 6, 1989
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 for product code HME

  • K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (July 6, 1993)
  • K914416 — BREATH-EASY, MODIFICATION (June 23, 1992)
  • 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)
  • 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