Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)— 510(k) K201316
Substantially EquivalentSuzhou Peaksonic Medical Technology Co., Ltd.
FDA 510(k) clearance K201316 for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD), Substantially Equivalent on 2021-02-26. Applicant: Suzhou Peaksonic Medical Technology Co., Ltd..
Clearance details
- Applicant
- Suzhou Peaksonic Medical Technology Co., Ltd.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qiandeng, Kunshan, Suzhou, CN
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.