Ultrasound Scanner Type 2102

• • Terminated Z-0271-05 FDA Unclassified (pre-2012) ·initiated 12 Nov 2004 ·via K000567, on the same 510(k)

  Defect at probe tip may effect sterilization and electrical safety

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K000567 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Diagnostic Ultrasound System, Type 3535, Modified

  Class II

  FDA 510(k) K926332 Active Cleared 28 Jun 1994

• Ultrasound Scanner 2001

  Class II

  FDA 510(k) K936024 Active Cleared 22 Aug 1995

• K-Kath Urethral Catheter Introducer

  Class II

  FDA 510(k) K802878 Active Cleared 2 Jan 1981

• Ultrasound Scanner, Model Type 2101

  Class II

  FDA 510(k) K991937 Active Cleared 30 Jul 1999

• Ultrasound Scanner Pro Focus, Model 2202

  Class II

  FDA 510(k) K043524 Active Cleared 13 Jan 2005

• Ultrasound Scanner, Type 1101

  Class II

  FDA 510(k) K002085 Active Cleared 1 Aug 2000

See all devices from B-K Medical A/S →