SUMMED INFLATION DEVICE KIT— 510(k) K133795
Substantially EquivalentSunny Medical Device (Shenzhen) Co., Ltd.
FDA 510(k) clearance K133795 for SUMMED INFLATION DEVICE KIT, Substantially Equivalent on 2014-12-12. Applicant: Sunny Medical Device (Shenzhen) Co., Ltd..
Clearance details
- Applicant
- Sunny Medical Device (Shenzhen) Co., Ltd.
- Product code
- Code MAV
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
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.