Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System— 510(k) K210318
Substantially EquivalentShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
FDA 510(k) clearance K210318 for Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System, Substantially Equivalent on 2021-08-18. Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.