Invasive Blood Pressure (Ibp) Function, Model 9500 Multigas Monitor

• • Terminated Z-0258-2007 FDA Unclassified (pre-2012) ·initiated 29 Sep 2006 ·on shared 510(k) K983250

  Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

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

510(k) Number

K983250 ↗

FDA Product Code

DSK

Device Class

Class II

Regulation

21 CFR Part 870.1110

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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