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Avoximeter Whole Blood CO-Oximeter

ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Model AVOX4000D · UDI-DI 10711234530252

JKS
8
510(k) clearances
6
Adverse events
1
Recalls
12
Facilities

Description

Avoximeter Whole Blood CO-Oximeter System - Instrument (Demonstration)

Recalls

DateFirmReason
2008-02-13International Technidyne Corp.Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to custom

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.