Data / Medical devices / China / Shenzhen Creative Industry Co., Ltd
Shenzhen Creative Industry Co., Ltd: FDA-registered device maker in SHENZHEN Guangdong, China, 8 510(k) clearances
Shenzhen Creative Industry Co., Ltd is registered with the FDA (registration 3006733253) in SHENZHEN Guangdong, China. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006733253
- Address
- Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road Xili Street, Nanshan District, SHENZHEN Guangdong, China, 518110
- Owner or operator
- SHENZHEN CREATIVE INDUSTRY CO., LTD (9104865)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 25, 2007
- Registered through
- 2026
- Brand names listed
- AP-10, All-in-One Health Monitor, ECG Monitor, FINGERTIP OXIMETER, Handheld Pulse Oximeter, SP-20, K10, K12, K15, KS-60A, KS-60F, KS-60FW, KS-60FB, KS-60FWB, KS-2, KS-60NW, KS-60NWB, S5, S5W, S5B, S5WB, S5G, S5WG and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Manufacturer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 25, 2021 | K201468 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| December 31, 2019 | K192343 | Patient Monitor | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| November 13, 2018 | K172792 | Handheld Pulse Oximeter, Model SP-20 | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| September 9, 2017 | K170047 | All-in-One Health Monitor, PC-303 | MWI | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| October 1, 2013 | K123711 | PATIENT MONITOR | MWI | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| December 7, 2012 | K120502 | PC-60NW FINGERTIP OXIMETER | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| January 10, 2008 | K073152 | PC-180 / PRINCE 180 EASY ECG MONITOR | DSH | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| July 13, 2007 | K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Magnetic Tape, Medical
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
Updated January 25, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.