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510(k) K803195

SYSTEM 1 INSTRUMENT STAND by Surgical Mechanical Research, Inc. — Product Code HMF

K803195 is an FDA 510(k) premarket notification submitted by Surgical Mechanical Research, Inc. for the device "SYSTEM 1 INSTRUMENT STAND". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. Surgical Mechanical Research, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1981
Date Received
December 16, 1980
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 Surgical Mechanical Research, Inc.

  • K800382 — CLEAR-VIEW MIRROR WARMER (May 14, 1980)
  • K800526 — SMR H-CHAIR (March 18, 1980)
  • K781801 — MAXI-CHAIR (November 3, 1978)

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