Ultrasound Probe Drape

• • Terminated Z-0384-05 FDA Unclassified (pre-2012) ·initiated 28 Sep 2000 ·on shared 510(k) K940151

  Defective packaging, potential for breech in sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K940151 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• The Pathfinder

  Not classified

  FDA 510(k) K842304 Active Cleared 1 Aug 1984

• X-Ray Drapes

  Class I

  FDA 510(k) K923099 Active Cleared 15 Oct 1992

• Sterile Disposable Spinal Needles

  Class II

  FDA 510(k) K834407 Active Cleared 19 Mar 1984

• Camera Cover with Tear Tip

  Class I

  FDA 510(k) K940152 Active Cleared 28 Oct 1994

• Easytop

  Not classified

  FDA 510(k) K853281 Active Cleared 21 Aug 1985

• Infant Scale Disposable Liner

  Class I

  FDA 510(k) K790659 Active Cleared 30 Apr 1979

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