E-PEN (E-PEN)— 510(k) K243143
Substantially EquivalentBomtech Electronics Co., Ltd.
FDA 510(k) clearance K243143 for E-PEN (E-PEN), Substantially Equivalent on 2025-04-07. Applicant: Bomtech Electronics Co., Ltd..
Clearance details
- Applicant
- Bomtech Electronics Co., Ltd.
- Product code
- Code QAI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Data sourced from openFDA. This site is unofficial and independent of the FDA.