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510(k) K935945

ROTA DATAMATE I by Rota Systems,Inc. — Product Code HMF

K935945 is an FDA 510(k) premarket notification submitted by Rota Systems,Inc. for the device "ROTA DATAMATE I". The FDA issued a decision of Substantially Equivalent on April 19, 1994. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1994
Date Received
December 13, 1993
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 for product code HMF

  • K935952 — ROTA SYSTEM 5000 (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)
  • K832073 — ELECTRIC INSTRUMENT TABLE (August 12, 1983)

FDA data resources