Home › Device types › BTY
Calculator, Predicted Values, Pulmonary Function
FDA product code BTY · Class 2 · Anesthesiology
205
Registered devices
136
Adverse events
4
Recalls
64
510(k) clearances
Devices with this code
Shape — Shape Medical Systems, Inc.Vmax — Carefusion CorporationCOSMED — C O S M E D SRLVyaire — Jaeger Medical GmbHVMAX — VYAIRE MEDICAL, INC.Jaeger — Jaeger Medical GmbHJaeger — Jaeger Medical GmbHShape-HF — Shape Medical Systems, Inc.Shape II System Refurbished — Shape Medical Systems, Inc.VMAX — VYAIRE MEDICAL, INC.Shape — Shape Medical Systems, Inc.Avea — VYAIRE MEDICAL, INC.VMAX — VYAIRE MEDICAL, INC.VMAX — VYAIRE MEDICAL, INC.Vmax — Carefusion CorporationFlowScreen — eResearchTechnology GmbHCOSMED — C O S M E D SRLCOSMED — C O S M E D SRLVmax — Carefusion CorporationVmax — Carefusion CorporationVmax — Carefusion CorporationShape-HF — Shape Medical Systems, Inc.Vyaire — Jaeger Medical GmbHVmax — Carefusion Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-15 | NDDd Medical Technologies, Inc. | The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a c |
| 2017-08-15 | NDDd Medical Technologies, Inc. | The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a c |
| 2014-12-23 | Shape Medical Systems, Inc | This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorre |
| 2014-05-28 | Shape Medical Systems, Inc | Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lo |
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 docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.