Home › NSPIRE HEALTH, INC. › nSpire Health
nSpire Health
NSPIRE HEALTH, INC. · Model KoKo Sx 1000 Diagnostic Spirometer · UDI-DI 00852417003347
BZG
Prescription
1
510(k) clearances
31
Adverse events
1
Recalls
94
Facilities
Description
KoKo Sx 1000 spirometer and software package, fully compatible with Iris server to allow support for networked data access, patient questionnaires, workflow, and HL7 connectivity.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.