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510(k) K894789

DMI 250 SERIES POWER SURGERY TABLE by M.D. Intl., Inc. — Product Code JEA

K894789 is an FDA 510(k) premarket notification submitted by M.D. Intl., Inc. for the device "DMI 250 SERIES POWER SURGERY TABLE". The FDA issued a decision of Substantially Equivalent on August 29, 1989. The device falls under product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. M.D. Intl., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1989
Date Received
July 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by M.D. Intl., Inc.

  • K894788 — DMI SERIES 90 EXAMINATION TABLE (September 8, 1989)
  • K870832 — OXY-THERM (March 12, 1987)
  • K771249 — JOY LIGHT (July 15, 1977)

Other clearances for product code JEA

  • K953071 — STRYKER COMMAND2 OFFICE CONSOLE (August 8, 1995)
  • K924094 — MEND APC (March 30, 1993)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K911522 — ARTHROBOT(TM) WRIST HOLDER ACCESSORY (April 29, 1991)
  • K900290 — SKYTRON MODEL 1100 AND MODEL 142 (February 20, 1990)
  • K881060 — OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) (March 25, 1988)
  • K874762 — ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (December 10, 1987)
  • K873080 — ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY (November 25, 1987)
  • K873079 — ARTHROBOT 100 UPPER LIMB POSITIONER (November 25, 1987)

FDA data resources