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FDA 510(k), K212153, Biobeat Platform, BB-613WP Patch
FDA 510(k), K212153, Biobeat Platform, BB-613WP Patch
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510(K) Number: K212153
Device Name: Biobeat Platform, BB-613WP Patch
Manufacturer: BioBeat Technologies Ltd.
Device Classification Name: Oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 07/09/2021
Decision Date: 03/25/2022
Regulation Medical Specialty: Cardiovascular
Device Name: Biobeat Platform, BB-613WP Patch
Manufacturer: BioBeat Technologies Ltd.
Device Classification Name: Oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 07/09/2021
Decision Date: 03/25/2022
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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