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510(k) K964273

DURA-BOARD ARMBOARD by Allen Medical Systems, Inc. — Product Code GDC

K964273 is an FDA 510(k) premarket notification submitted by Allen Medical Systems, Inc. for the device "DURA-BOARD ARMBOARD". The FDA issued a decision of Substantially Equivalent on January 8, 1997. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. Allen Medical Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1997
Date Received
October 28, 1996
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 Allen Medical Systems, Inc.

  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER (March 12, 1996)
  • K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
  • K921168 — ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (April 21, 1993)

Other clearances for product code GDC

  • K971390 — QUANTUM 3080SP SURGICAL TABLE (May 15, 1997)
  • K970807 — MOBILE OPERATING TABLE 1132.01 (March 14, 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)
  • K853535 — TRAUMA TABLE (September 11, 1985)

FDA data resources