FDA 510(k), K212153, Biobeat Platform, BB-613WP Patch

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

417 pages (1,393 of 1,810 original pages are fully redacted)