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510(k) K873478

SKYTRON MODEL 130 SURGICAL TABLE by Skytron, Div. the Kmw Group, Inc. — Product Code FWY

K873478 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON MODEL 130 SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on September 24, 1987. The device falls under product code FWY (Table, Operating-Room, Non-Electrical), a Class I device regulated under 21 CFR 878.4950. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1987
Date Received
August 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Non-Electrical
Device Class
Class I
Regulation Number
878.4950
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 FWY

  • K883457 — ASST-3000 SPINAL SURGERY TABLE (August 26, 1988)
  • K833509 — CHEMONUCLEOLYSIS TABLE (November 28, 1983)
  • K800118 — CHICK SURGICAL TABLE (February 5, 1980)

FDA data resources