JASUN, MODELS DT-01F AND DT-11F— 510(k) K030361
Substantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,
FDA 510(k) clearance K030361 for JASUN, MODELS DT-01F AND DT-11F, Substantially Equivalent on 2003-02-21. Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,.
Clearance details
- Applicant
- Hangzhou Hua'An Medical & Health Instruments Co.,
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barrington, IL, US
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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.