FDA 510(k) · Biobeat
K212153: Biobeat Platform, BB-613WP Patch (Biobeat Technologies , Ltd.)
Biobeat Technologies , Ltd. received FDA 510(k) K212153 for Biobeat Platform, BB-613WP Patch, with a decision date of Mar 25, 2022 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K212153 |
|---|---|
| Pathway | 510(k) |
| Applicant | Biobeat Technologies , Ltd. |
| Device name | Biobeat Platform, BB-613WP Patch |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 9, 2021 |
| Decision date | Mar 25, 2022 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K212153
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.