Home › Device types › BZK
Spirometer, Monitoring (W/Wo Alarm)
FDA product code BZK · Class 2 · Anesthesiology
107
Registered devices
136
Adverse events
3
Recalls
61
510(k) clearances
Devices with this code
NA — GE Healthcare Finland OyCARESCAPE B850 — GE Healthcare Finland OyExSpiron 2Xi — Senzime AB (Publ.)NA — GE Healthcare Finland OyNA — GE Healthcare Finland OyPatient Monitor — Edan Instruments, Inc.CARESCAPE B650 — GE Healthcare Finland OyNA — GE Healthcare Finland OyetCO2 Respiratory Mechanics Pod — DRAEGER MEDICAL SYSTEMS, INC.ExSpiron 1Xi — Respiratory Motion Inc.CARESCAPE Software — GE Healthcare Finland OyNA — GE Healthcare Finland OyNA — GE Healthcare Finland OyMGC Diagnostics — MEDICAL GRAPHICS CORPORATIONKoKo — KOKO PFT LTDNA — GE Healthcare Finland OyNA — GE Healthcare Finland OyNA — GE Healthcare Finland OyNA — GE Healthcare Finland OyCARESCAPE — GE Healthcare Finland OyExSpiron Pediatric PadSets — Senzime AB (Publ.)NA — GE Healthcare Finland OyAincA® — ANESTHESIA ASSOCIATES, INC.nSpire Health — NSPIRE HEALTH LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-01 | Mindray DS USA, Inc. dba Mindray North America | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. |
| 2011-07-29 | Respironics Novametrix, LLC. | Pressure lines maybe occluded and display incorrect tidal volumes. |
| 2011-07-29 | Respironics Novametrix, LLC. | Pressure lines maybe occluded and display incorrect tidal volumes. |
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