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November 7, 2001
Company: Novametrix Medical Systems, IncDate of Enforcement Report: 11/7/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3 REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values. MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems, Inc., Wallingford, CT RECALLED BY: Recalling firm by letter on 7/9/01 FIRM...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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