babyLance Safety Heelstick (BLM, BLN, BLP)— 510(k) K223900
Substantially EquivalentClinical Innovations, LLC
FDA 510(k) clearance K223900 for babyLance Safety Heelstick (BLM, BLN, BLP), Substantially Equivalent on 2023-02-24. Applicant: Clinical Innovations, LLC. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, LLC
- Product code
- Code FMK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
Recent devices under product code FMK
view allMore clearances from Clinical Innovations, LLC
view allAdverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
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.