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EasyOne Sky Spirometer

NDD Medizintechnik AG · Model 2800-1 · UDI-DI 07640142190554

BZG Prescription
1
510(k) clearances
31
Adverse events
1
Recalls
94
Facilities

Recalls

DateFirmReason
2024-10-11Baxter Healthcare CorporationThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System

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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.