Biobeat Platform-2 and BB-613WP Patch
K-Number: K222010 · 2022-12-30
ApplicantBiobeat Technologies , Ltd.
Decision Date2022-12-30
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Biobeat Platform-2 and BB-613WP Patch is a medical device manufactured by Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2022-12-30 under approval number K222010. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biobeat Platform-2 and BB-613WP Patch?
Biobeat Platform-2 and BB-613WP Patch is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Biobeat Technologies , Ltd.. The 510(k) number is K222010.
When was Biobeat Platform-2 and BB-613WP Patch approved by the FDA?
Biobeat Platform-2 and BB-613WP Patch received FDA 510(k) clearance on 2022-12-30, under approval number K222010.
What company makes Biobeat Platform-2 and BB-613WP Patch?
Biobeat Platform-2 and BB-613WP Patch is manufactured by Biobeat Technologies , Ltd..
What is the FDA product code for Biobeat Platform-2 and BB-613WP Patch?
The FDA product code for Biobeat Platform-2 and BB-613WP Patch is DQA.
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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.