Shenzhen Creative Industry Co., Ltd
SHENZHEN Guangdong, CN
SHENZHEN CREATIVE INDUSTRY CO., LTD appears in FDA device records in SHENZHEN Guangdong, CN. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Shenzhen Creative Industry Co., Ltd between 2007 and 2021. The busiest year on record is 2007, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201468 | Pulse Oximeter | DQA | Substantially Equivalent | |
| K192343 | Patient Monitor | DQA | Substantially Equivalent | |
| K172792 | Handheld Pulse Oximeter, Model SP-20 | DQA | Substantially Equivalent | |
| K170047 | All-in-One Health Monitor, PC-303 | MWI | Substantially Equivalent | |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 | DQA | Substantially Equivalent | |
| K123711 | PATIENT MONITOR | MWI | Substantially Equivalent | |
| K120502 | PC-60NW FINGERTIP OXIMETER | DQA | Substantially Equivalent | |
| K093016 | VITAL SIGNS MONITOR | DQA | Substantially Equivalent | |
| K082055 | MODEL PC-860 FETAL DOPPLER | KNG | Substantially Equivalent | |
| K073152 | PC-180 / PRINCE 180 EASY ECG MONITOR | DSH | Substantially Equivalent | |
| K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | DQA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006733253 | 3006733253 | SHENZHEN CREATIVE INDUSTRY CO., LTD | Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, SHENZHEN Guangdong 518110 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- FLLContinuous Measurement Thermometer
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- KNGMonitor, Ultrasonic, Fetal
- DQAOximeter
- OCHOximeter, Infrared, Sporting, Aviation
- PGJOximeter, Wellness
- DSHRecorder, Magnetic Tape, Medical
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain