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FDA 510(k), K190792, BB-613WP
FDA 510(k), K190792, BB-613WP
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510(K) Number: K190792
Device Name: BB-613WP
Manufacturer: BioBeat Technologies Ltd.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 03/27/2019
Decision Date: 08/22/2019
Regulation Medical Specialty: Cardiovascular
Device Name: BB-613WP
Manufacturer: BioBeat Technologies Ltd.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 03/27/2019
Decision Date: 08/22/2019
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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