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510(k) K953246

OCTOROLL by Octostop, Inc. — Product Code KXH

K953246 is an FDA 510(k) premarket notification submitted by Octostop, Inc. for the device "OCTOROLL". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code KXH (Cradle, Patient, Radiologic), a Class I device regulated under 21 CFR 892.1830. Octostop, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
July 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cradle, Patient, Radiologic
Device Class
Class I
Regulation Number
892.1830
Review Panel
RA
Submission Type

Other clearances by Octostop, Inc.

  • K972766 — PIVOTING COMPENSATING FILTERS FOR THE HEAD (August 14, 1997)
  • K963941 — THE PHARAOH COMPENSATING FILTER (November 27, 1996)
  • K952871 — RIDGES PLUS (July 20, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K940306 — OCTOSTOP COMPENSATING FILTERS (September 6, 1994)
  • K935444 — OCTOSTOP(R) CHAIR (NEW MODEL (September 2, 1994)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K926069 — WRIST TRACTION (January 21, 1993)
  • K913711 — GENTLE SLOPE (October 14, 1992)

Other clearances for product code KXH

  • K122174 — PEDIATRIC POSITIONER PAD SET (November 16, 2012)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K884292 — STRETCHER TABLE (March 31, 1989)
  • K863890 — MAMM-AIRE (October 14, 1986)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)

FDA data resources