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510(k) K853149

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 by F. & F. Koenigkramer — Product Code HME

K853149 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE 1000, RELIANCE 1500, RELIANCE 2000". The FDA issued a decision of Substantially Equivalent on September 5, 1985. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
July 29, 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 F. & F. Koenigkramer

  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K853150 — RELIANCE 6100 (September 5, 1985)
  • K853151 — RELIANCE 5000 (September 5, 1985)
  • K843046 — RELIANCE TREATMENT CABINET (September 27, 1984)
  • K834060 — RELIANCE OPHTHALMIC SLIT LAMP R-083 (February 4, 1984)
  • K831568 — RELIANCE TEMPO OPHTH. INSTR STAND (June 30, 1983)
  • K812544 — RELIANCE OPHTHALMIC INSTRUMENT CONTROL (September 21, 1981)
  • K761147 — RELIANCE MOD-U-LINE M-700 (January 28, 1977)

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)
  • K864494 — MODEL 6500 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)
  • K853151 — RELIANCE 5000 (September 5, 1985)

FDA data resources