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Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
FDA product code CBR · Class 2 · Anesthesiology
160
Registered devices
21
Adverse events
3
Recalls
5
510(k) clearances
Devices with this code
NA — GE Medical Systems Information Technologies, Inc.IRMA™ Airway Adapter — MASIMO CORPORATIONCARESCAPE B450 — GE Healthcare Finland OyNA — GE Healthcare Finland OyISA™ OR+ — MASIMO CORPORATIONNA — GE Healthcare Finland OyNA — GE Healthcare Finland OyADVANCED PATIENT MONITOR — ADVANCED INSTRUMENTATIONS, INC.NA — GE Medical Systems Information Technologies, Inc.Waveline EZ-MAX — AvanteCARESCAPE — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CARESCAPE — GE Healthcare Finland OySpacelabs — SPACELABS HEALTHCARE (WASHINGTON), INCMetaphor Flow Sensor — TREYMED INCAG Module(O2/package/accessory) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.COMEN — Shenzhen Comen Medical Instruments Co., Ltd.NA — GE Healthcare Finland OyPatient Monitor — Edan Instruments, Inc.CARESCAPE B650 — GE Healthcare Finland OyCARESCAPE — GE Healthcare Finland OyNA — GE Healthcare Finland OyNA — GE Healthcare Finland OyCARESCAPE — GE Healthcare Finland OyN/A — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-18 | Spacelabs Healthcare Inc | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. |
| 2011-06-08 | Spacelabs Healthcare, Llc | Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The e |
| 2007-10-08 | Spacelabs Healthcare, Incorporated | Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. |
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