Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192514
Patient Monitor · Edan Instruments, Inc. · decided 2020-04-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ECG Cable | 6-lead, Clip, IEC, Adult/pediatric | Edan Instruments, Inc. | DSA | 06944413815735 |
| ECG cable | 5-Lead, 12pin, ESU, clip, IEC, reusable | Edan Instruments, Inc. | DSA | 06944413805088 |
| Temperature Probe | rectal/oral ,neonatal/Infant,3m,reusable | Edan Instruments, Inc. | FLL | 06944413804760 |
| ECG Cable | 6-lead, 12-pin, Defib-proof, Adult/pediatric | Edan Instruments, Inc. | DSA | 06944413815704 |
| ECG cable | 5-Lead, 12pin, ESU, snap, AHA, reusable | Edan Instruments, Inc. | DSA | 06944413805118 |
| Patient Monitor | X8s | Edan Instruments, Inc. | CCK DQA DRT DSB DSI DSK DXN FLL MHX MLD | 06944413814752 |
| NIBP Tube | NIBP Tube for neonatal cuff, 3m | Edan Instruments, Inc. | DXQ | 06944413804944 |
| SpO2 Sensor | SHD-I , Infant, disposable | Edan Instruments, Inc. | DQA | 06944413805415 |
| ECG trunk cable | 3-Lead, 12pin, Defib, AHA/IEC, 5.0m, reusable | Edan Instruments, Inc. | DSA | 06944413805194 |
| ECG trunk cable | 3-Lead, 12pin, Defib, AHA/IEC, 2.7m, reusable | Edan Instruments, Inc. | DSA | 06944413805187 |
| ECG limb cable | 3-lead, snap, AHA, 0.63m, neonate, reusable | Edan Instruments, Inc. | DSA | 06944413803862 |
| ECG cable | 5-Lead, 12pin, ESU, clip, AHA, reusable | Edan Instruments, Inc. | DSA | 06944413805095 |
| ECG Cable | 6-lead, Clip, AHA, Adult/pediatric | Edan Instruments, Inc. | DSA | 06944413815711 |
| SpO2 Sensor | SHD-N, Neonate, disposable | Edan Instruments, Inc. | DQA | 06944413805408 |
| ECG limb cable | 3-lead, clip, AHA, 0.63m, DIN, reusable | Edan Instruments, Inc. | DSA | 06944413803879 |
| Patient Monitor | X8 | Edan Instruments, Inc. | CCK DQA DRT DSB DSI DSK DXN FLL MHX MLD | 06944413810907 |
| Patient Monitor | X10s | Edan Instruments, Inc. | CCK DQA DRT DSB DSI DSK DXN FLL MHX MLD | 06944413814387 |
| Temperature Probe | rectal/oral ,neonatal/Infant,3m,reusable | Edan Instruments, Inc. | FLL | 06944413804784 |
| ECG limb cable | 3-lead, clip, IEC, 0.63m, DIN, reusable | Edan Instruments, Inc. | DSA | 06944413803893 |
| ECG trunk cable | 3-Lead, 12pin, ESU, AHA/IEC, 2.7m, reusable | Edan Instruments, Inc. | DSA | 06944413805163 |
| ECG trunk cable | 3-Lead, 12pin, ESU, AHA/IEC, 5.0m, reusable | Edan Instruments, Inc. | DSA | 06944413805170 |
| ECG cable | 5-Lead, 12pin, ESU, snap, IEC, reusable | Edan Instruments, Inc. | DSA | 06944413805101 |
| Patient Monitor | X10 | Edan Instruments, Inc. | CCK DQA DRT DSB DSI DSK DXN FLL MHX MLD | 06944413810921 |
| ECG trunk cable | 3-lead, 12pin, Defib, AHA/IEC, 2.9m, DIN, reusable | Edan Instruments, Inc. | DSA | 06944413803855 |
| Patient Monitor | X12s | Edan Instruments, Inc. | CCK DQA DRT DSB DSI DSK DXN FLL MHX MLD | 06944413814769 |