Broncho Videoscope System— 510(k) K231521
Substantially EquivalentScivita Medical Technology Co., Ltd.
FDA 510(k) clearance K231521 for Broncho Videoscope System, Substantially Equivalent on 2023-11-14. Applicant: Scivita Medical Technology Co., Ltd..
Clearance details
- Applicant
- Scivita Medical Technology Co., Ltd.
- Product code
- Code EOQ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.