Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle— 510(k) K161950
Substantially EquivalentPromisemed Hangzhou Meditech Co., Ltd.
FDA 510(k) clearance K161950 for Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle, Substantially Equivalent on 2017-05-11. Applicant: Promisemed Hangzhou Meditech Co., Ltd..
Clearance details
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.