E-PEN (E-PEN)
K-Number: K243143 · 2025-04-07
ApplicantBomtech Electronics Co., Ltd.
Decision Date2025-04-07
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
E-PEN (E-PEN) is a medical device manufactured by Bomtech Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under approval number K243143. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the E-PEN (E-PEN)?
E-PEN (E-PEN) is a medical device that received FDA 510(k) clearance on 2025-04-07. It is manufactured by Bomtech Electronics Co., Ltd.. The 510(k) number is K243143.
When was E-PEN (E-PEN) approved by the FDA?
E-PEN (E-PEN) received FDA 510(k) clearance on 2025-04-07, under approval number K243143.
What company makes E-PEN (E-PEN)?
E-PEN (E-PEN) is manufactured by Bomtech Electronics Co., Ltd..
What is the FDA product code for E-PEN (E-PEN)?
The FDA product code for E-PEN (E-PEN) is QAI.
Other Devices by Bomtech Electronics Co., Ltd.
Related Devices (Code: QAI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.