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Device, Galvanic Skin Response Measurement

FDA product code GZO · Class 2 · Neurology

76
Registered devices
30
Adverse events
3
Recalls
26
510(k) clearances

Devices with this code

Empatica Health Monitoring Platform — EMPATICA SRLQUEX ED — QX WORLD LTDCadwell Guardian — CADWELL INDUSTRIES, INC.IOMAX Adapter — CADWELL INDUSTRIES, INC.Cascade IOMAX — CADWELL INDUSTRIES, INC.SUDOSCAN — IMPETO MEDICALGD — General DevicesIOMAX Extender Pod — CADWELL INDUSTRIES, INC.QUEX S — QX WORLD LTDHappy Health — HAPPY HEALTH, INC.Cascade IOMAX — CADWELL INDUSTRIES, INC.SweatC — LD TECHNOLOGY, LLCWithings® — WITHINGSSUDOSCAN® — IMPETO MEDICALZYTO Hand Cradle — Zyto Technologies, Inc.Empatica Health Monitoring Platform — EMPATICA SRLSudoCheck — Medeia, Inc.GD — General DevicesCadwell — CADWELL INDUSTRIES, INC.Empatica — EMPATICA SRLSUDOSCAN — IMPETO MEDICALCascade IOMAX Intraoperative Monitor — CADWELL INDUSTRIES, INC.SUDOSCAN — IMPETO MEDICALEmpatica Health Monitoring Platform — EMPATICA SRL

Recent recalls

DateFirmReason
2018-07-02Hudson Scientific LLCThe device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three compla
2015-11-23ZYTO Technologies, Inc.ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
2015-11-23ZYTO Technologies, Inc.ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

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