K212153 is an FDA 510(k) clearance for the Biobeat Platform, BB-613WP Patch. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Biobeat Technologies , Ltd. (Petah Tikvah, IL). The FDA issued a Cleared decision on March 25, 2022, 259 days after receiving the submission on July 9, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K212153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2021 |
| Decision Date | March 25, 2022 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |