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510(k) K812544

RELIANCE OPHTHALMIC INSTRUMENT CONTROL by F. & F. Koenigkramer — Product Code HMF

K812544 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE OPHTHALMIC INSTRUMENT CONTROL". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
September 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.1860
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)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (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)
  • K761147 — RELIANCE MOD-U-LINE M-700 (January 28, 1977)

Other clearances for product code HMF

  • K935952 — ROTA SYSTEM 5000 (April 19, 1994)
  • K935945 — ROTA DATAMATE I (April 19, 1994)
  • K931839 — ROTA SYSTEM XL (November 22, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K924780 — BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (April 5, 1993)
  • K924771 — BURTON OPHTHALMIC STAND - MODEL XL3200 (April 5, 1993)
  • K913961 — OPHTHALMIC STAND (December 4, 1991)
  • K853358 — RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (October 4, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K844363 — OPHTHALMIC STAND (December 5, 1984)

FDA data resources