FDA 510(k) · Shenzhen Witleaf Medical Electronics
K213430: Fingertip Pulse Oximeter (Shenzhen Witleaf Medical Electronics Co., Ltd.)
Shenzhen Witleaf Medical Electronics Co., Ltd. received FDA 510(k) K213430 for Fingertip Pulse Oximeter, with a decision date of Dec 30, 2022 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K213430 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Witleaf Medical Electronics Co., Ltd. |
| Device name | Fingertip Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 21, 2021 |
| Decision date | Dec 30, 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
Statement 4-2／2 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: 2021/11/17
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.
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.