FDA 510(k) · Shenzhen BSX Technology Electronics
K202324: Fingertip Pulse Oximeter (Shenzhen Bsx Technology Electronics Co., Ltd.)
Shenzhen Bsx Technology Electronics Co., Ltd. received FDA 510(k) K202324 for Fingertip Pulse Oximeter, with a decision date of Dec 14, 2020 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K202324 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Bsx Technology Electronics Co., Ltd. |
| Device name | Fingertip Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 17, 2020 |
| Decision date | Dec 14, 2020 |
| 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.
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.