SignalMark Breast Marker— 510(k) K190689
Substantially EquivalentView Point Medical, Inc.
FDA 510(k) clearance K190689 for SignalMark Breast Marker, Substantially Equivalent on 2019-08-14. Applicant: View Point Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- View Point Medical, Inc.
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code NEU
view allMore clearances from View Point Medical, Inc.
view allAdverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
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.