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nSpire Health
NSPIRE HEALTH, INC. · Model KoKo Px 4000 Pulmonary Function System · UDI-DI 00852417003408
BZG
Prescription
1
510(k) clearances
31
Adverse events
1
Recalls
93
Facilities
Description
Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance, and optional Maximum Pressures (MIP/MEP) tests.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-11 | Baxter Healthcare Corporation | There 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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Get your free API keyRead the docsData 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.