Panels › Cardiovascular › Product code DXH · Class 2
Transmitters And Receivers, Electrocardiograph, Telephone
Regulation 870.2920
4510(k)s in 12 months (297 all time)
1recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in DXH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | GE Medical Systems China Co., Ltd. MAC 5 A4 Resting ECG Analysis System 855001-001;
MAC 5 A5 Resting ECG Analysis System 8855002-001.
Electrocardiograph Open, Classified |
DXH | K221321 |
| Oct 30, 2015 | Spacelabs Healthcare Inc Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00
Product Usage: The CardioCall event recorder is worn by the patient to record a short Terminated |
DXH | K972649 |
| Feb 18, 2015 | Alivecor SFO Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and Terminated |
DXH | K140933 |
| Nov 17, 2011 | Lifewatch Services Inc ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no Terminated |
DXH | K071995 K081257 +2 |
| Nov 17, 2011 | Lifewatch Services Inc LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no pa Terminated |
DXH | K081257 K110499 |
| Nov 17, 2011 | Lifewatch Services Inc LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either Terminated |
DXH | K071995 K101639 |
| Feb 25, 2010 | Cybernet Systems Corp. Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-381.
The device is for a remote medical data collection device for the monitoring of patient Terminated |
DXH | K020534 K050951 |
| Feb 25, 2010 | Cybernet Systems Corp. Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-386.
The device is for a remote medical data collection device for the monitoring of patien Terminated |
DXH | K020534 K050951 |
| Feb 25, 2010 | Cybernet Systems Corp. Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380.
The device is for a remote medical data collection device for the monitoring of patient Terminated |
DXH | K020534 K050951 |
| Feb 25, 2010 | Cybernet Systems Corp. Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-210.
The device is for a remote medical data collection device for the monitoring of patien Terminated |
DXH | K020534 K050951 |
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