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510(k) K900290

SKYTRON MODEL 1100 AND MODEL 142 by Skytron, Div. the Kmw Group, Inc. — Product Code JEA

K900290 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON MODEL 1100 AND MODEL 142". The FDA issued a decision of Substantially Equivalent on February 20, 1990. The device falls under product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1990
Date Received
January 22, 1990
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 Skytron, Div. the Kmw Group, Inc.

  • K071698 — AURORA LED SERIES SURGICAL LIGHTS (July 6, 2007)
  • K021585 — STELLAR SERIES SURGICAL LIGHTS WITH HERMES (November 13, 2002)
  • K002463 — STELLAR (November 8, 2000)
  • K992090 — MILLENNIUM GOLD (September 8, 1999)
  • K950192 — SKYTRON SKYBOOM SERIES (April 3, 1995)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K926045 — SKYTRON LIFE ISLAND 21 (July 27, 1993)
  • K915285 — SKYTRON INFINITY SERIES SURGICAL LIGHTS (February 20, 1992)
  • K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (September 4, 1990)

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)
  • K894789 — DMI 250 SERIES POWER SURGERY TABLE (August 29, 1989)
  • 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