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510(k) K851021

MAYFIELD TABLE-ELECTRIC by Ohio Medical Instrument Co., Inc. — Product Code GDC

K851021 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "MAYFIELD TABLE-ELECTRIC". The FDA issued a decision of Substantially Equivalent on May 21, 1985. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1985
Date Received
March 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Electrical
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Ohio Medical Instrument Co., Inc.

  • K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (July 29, 2002)
  • K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM (April 4, 2002)
  • K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / (November 2, 1999)
  • K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYST (July 12, 1999)
  • K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 (November 19, 1998)
  • K982244 — MAYFIELD ACCISS OPTICAL SYSTEM (September 23, 1998)
  • K960807 — TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 (May 17, 1996)
  • K953124 — MAYFIELD RADIOLUCENT 2000 SKULL CLAMP (February 9, 1996)
  • K941558 — MAYFIELD CHILD DISPOSABLE SKULL PIN (December 6, 1995)
  • K934289 — MAYFIELD RADIOLUCENT SKULL CLAMP (January 7, 1994)

Other clearances for product code GDC

  • K971390 — QUANTUM 3080SP SURGICAL TABLE (May 15, 1997)
  • K970807 — MOBILE OPERATING TABLE 1132.01 (March 14, 1997)
  • K964273 — DURA-BOARD ARMBOARD (January 8, 1997)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K934744 — MIDMARK MAGNUM GENERAL SURGICAL TABLE (March 28, 1994)
  • K914758 — MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (December 19, 1991)
  • K915393 — MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE (December 17, 1991)
  • K883613 — OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (September 15, 1988)
  • K853720 — MOBILE OPERATING TABLE FOR ORL MICROSURGERY (October 18, 1985)
  • K853480 — SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (September 12, 1985)

FDA data resources