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510(k) K850168

STILLE SCANDIA OPERATING TABLES RC 3000,1100 by Stille-Werner (Usa), Inc. — Product Code GDC

K850168 is an FDA 510(k) premarket notification submitted by Stille-Werner (Usa), Inc. for the device "STILLE SCANDIA OPERATING TABLES RC 3000,1100". The FDA issued a decision of Substantially Equivalent on March 28, 1985. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1985
Date Received
January 16, 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 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