SaviSafe Safety Device— 510(k) K230287
Substantially EquivalentSuzhou Savicred Biotechnology Co., Ltd.
FDA 510(k) clearance K230287 for SaviSafe Safety Device, Substantially Equivalent on 2023-11-21. Applicant: Suzhou Savicred Biotechnology Co., Ltd..
Clearance details
- Applicant
- Suzhou Savicred Biotechnology Co., Ltd.
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.