Modification to Mcare 300 Vital Signs Monitor, Model 91220

• • Terminated Z-3185-2011 FDA Unclassified (pre-2012) ·initiated 14 Apr 2010 ·on shared 510(k) K082045

  There have been reports that the Spacelabs Medical Vital Signs Monitor, Model 91220, will not power up with AC power and will no longer charge the batteries.

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

510(k) Number

K082045 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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