FDA 510(k) · Biobeat
K190792: BB-613WP (Biobeat Technologies , Ltd.)
Biobeat Technologies , Ltd. received FDA 510(k) K190792 for BB-613WP, with a decision date of Aug 22, 2019 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))
FDA facts
| FDA number | K190792 |
|---|---|
| Pathway | 510(k) |
| Applicant | Biobeat Technologies , Ltd. |
| Device name | BB-613WP |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Mar 27, 2019 |
| Decision date | Aug 22, 2019 |
| 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
The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The BB-613WP can also track changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using oscillometric blood pressure monitor. The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
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 K190792
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.