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510(k) K870205

ROTAX-II BI-PLANE CIRCULAR ARM by B C Medical , Ltd.

K870205 is an FDA 510(k) premarket notification submitted by B C Medical , Ltd. for the device "ROTAX-II BI-PLANE CIRCULAR ARM". The FDA issued a decision of Substantially Equivalent on March 6, 1987. B C Medical , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1987
Date Received
January 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by B C Medical , Ltd.

  • K946378 — BCM 400CP (May 4, 1995)
  • K933100 — ARC-600 (November 8, 1993)
  • K933035 — BCM-600TX (October 8, 1993)
  • K920862 — BCM-400C (September 30, 1992)
  • K890306 — BCM-ARC 105 X-RAY MOBILE UNIT (April 17, 1989)
  • K801950 — BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO (October 3, 1980)
  • K801949 — BCM-302 COLLIMATING CONE & COMPENSATIN (October 3, 1980)

FDA data resources