NEOSHIELD— 510(k) K172499
Substantially EquivalentJMS North America Corporation
FDA 510(k) clearance K172499 for NEOSHIELD, Substantially Equivalent on 2018-06-01. Applicant: JMS North America Corporation.
Clearance details
- Applicant
- JMS North America Corporation
- Product code
- Code ONB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
Adverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
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.