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510(k) K832887

ELECTRONIC UNIT by Surgi-Quip Inc.U — Product Code EPT

K832887 is an FDA 510(k) premarket notification submitted by Surgi-Quip Inc.U for the device "ELECTRONIC UNIT". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700. Surgi-Quip Inc.U has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
August 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Surgi-Quip Inc.U

  • K841115 — CHARLES/MCINTYRE GIANT BREAK TABLE (May 9, 1984)
  • K841116 — MOBILE OPHTHALMIC OPERATING TABLE (May 9, 1984)
  • K840004 — WEE BAG O'MERCURY (March 22, 1984)
  • K822554 — CEMENT EXTRACTION INSTRUMENTATION (September 14, 1982)
  • K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. . (September 14, 1982)
  • K822426 — MCINTYRE MICROSCOPE STAND (September 2, 1982)
  • K822428 — SURGI-QUIP MICROSCOPE STAND (September 2, 1982)

Other clearances for product code EPT

  • K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (July 1, 1994)
  • K931284 — MICRODYNE OFFICE SURGICAL MICROSCOPE (November 18, 1993)
  • K933310 — MICRINS CONTRAST BACKGROUND MATERIAL (August 19, 1993)
  • K903412 — STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (September 20, 1990)
  • K883581 — OPMI CS (September 13, 1988)
  • K882269 — STORZ DIAGNOSTIC MICROSCOPE SYSTEM (June 23, 1988)
  • K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (April 30, 1986)
  • K844858 — STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (March 25, 1985)
  • K823011 — VC III (November 8, 1982)
  • K822561 — MICROSCOPE (September 14, 1982)

FDA data resources