1 device · 1 company · 2020
Product code BZG: Spirometer, Diagnostic
1 device under product code BZG, 2020, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Spirometer, Diagnostic. 21 CFR 868.1840, Class II. MAUDE held 31 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Air NextK183089 · 510(k) | NuvoAir AB | Anesthesiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.