Ultrasonic Pocket Doppler (SpO2 and PR detection function) clinical investigation data
| Title | Ultrasonic Pocket Doppler (SpO2 and PR detection function) clinical investigation data |
|---|---|
| Description | In order to evaluate the safety and efficacy of SD2 series Ultrasonic Pocket Doppler, which is producted by EDAN INSTRUMENTS, Inc. Guangzhou Overseas Chinese Hospital had implemented a clinical investigation in July 2022. This investigation is an invasive controlled desaturation study on healthy aldult volenteers, according to the standards ISO 80601-2-61:2017 and YY 0784-2010, etc. This investigaton enrolled 14 human subjects, gender, age, height, weight, skin color and thumb circumference were collected, 344 groups of SpO2-SaO2, PR-HR data were measured and used to compile statistic and analysis to evaluate the investigational medical device. |
| Organism | Homo sapiens |
| Data Type | Demographic Data |
| Data Accessibility | Controlled-access |
| BioProject | PRJCA012243 |
| Release Date | 2022-10-01 |
| Submitter | Yalan Li (13500013993@139.com) |
| Organization | Guangzhou Overseas Chinese Hospital |
| Submission Date | 2022-09-30 |
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| File ID | File Title | Number/Samples | File Type | File Size | File Suffix | Download Times | Download |
|---|---|---|---|---|---|---|---|
| OMIX002000-01 | Ultrasonic Pocket Doppler (SpO2 and PR detection function) clinical investigation data | 1 | Demographic Data | 173.3 KB | zip | 0 | Controlled |