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510(k) K970807

MOBILE OPERATING TABLE 1132.01 by Stierlen-Maquet AG — Product Code GDC

K970807 is an FDA 510(k) premarket notification submitted by Stierlen-Maquet AG for the device "MOBILE OPERATING TABLE 1132.01". The FDA issued a decision of Substantially Equivalent on March 14, 1997. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. Stierlen-Maquet AG has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1997
Date Received
March 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Table, Operating-Room, Electrical
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Stierlen-Maquet AG

  • K926525 — BETASTAR 1131.02 MOBILE OPERATING TABLE (October 12, 1993)
  • K920890 — OPERATING TABLE SYSTEM-BETAMAQUET 1140 (July 2, 1992)
  • K883613 — OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (September 15, 1988)
  • K873274 — PLASTER TABLE 1418 (September 17, 1987)
  • K873275 — EXTENSION TABLE 1417 (September 17, 1987)
  • K873276 — EXTENSION DEVICE 1416 (September 17, 1987)
  • K873273 — ORTHOPAEDIC TABLE 1420 (September 17, 1987)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K843134 — MOBILE OPERATING TABLE HEIDELBERGS 1130 (September 7, 1984)

Other clearances for product code GDC

  • K971390 — QUANTUM 3080SP SURGICAL TABLE (May 15, 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)
  • K853535 — TRAUMA TABLE (September 11, 1985)

FDA data resources