FDA 510(k) · Shenzhen Creative Industry
K120502: PC-60NW FINGERTIP OXIMETER (Shenzhen Creative Industry Co., Ltd.)
Shenzhen Creative Industry Co., Ltd. received FDA 510(k) K120502 for PC-60NW FINGERTIP OXIMETER, with a decision date of Dec 7, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K120502 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Creative Industry Co., Ltd. |
| Device name | PC-60NW FINGERTIP OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Feb 21, 2012 |
| Decision date | Dec 7, 2012 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Abbreviated |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Indications for Use 510(k) Number (if known): I C, Device Name: PC-60NW Fingertip Oximeter Indications For Use: The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spot- checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device isrecommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick. Prescription Use AND/OR Over-The-Counter Use '4 (Part 21 CFR 801 Subp~art'D) (21 CFR s0i Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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.