BB-613-BPM
K-Number: K241066 · 2025-01-14
ApplicantBiobeat Technologies , Ltd.
Decision Date2025-01-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BB-613-BPM is a medical device manufactured by Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2025-01-14 under approval number K241066. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BB-613-BPM?
BB-613-BPM is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Biobeat Technologies , Ltd.. The 510(k) number is K241066.
When was BB-613-BPM approved by the FDA?
BB-613-BPM received FDA 510(k) clearance on 2025-01-14, under approval number K241066.
What company makes BB-613-BPM?
BB-613-BPM is manufactured by Biobeat Technologies , Ltd..
What is the FDA product code for BB-613-BPM?
The FDA product code for BB-613-BPM is DXN.
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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.