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EEG Module w/ Cable

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Model 115-053713-00 · UDI-DI 06936415905569

OLW Prescription
1
510(k) clearances
347
Adverse events (1 deaths)
1
Recalls
36
Facilities

Recalls

DateFirmReason
2018-07-26Covidien LLCRevised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

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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.