Shenzhen Creative Industry Co., Ltd.

FDA Regulatory Profile

Shenzhen Creative Industry Co., Ltd. has 0 FDA recalls, 2 inspections, 11 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 6, 2015 · OAI
Latest 510(k)
Jan 25, 2021

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
11
Inspections
2
Compliance Actions
1

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 6, 2015Shenzhen, ChinaDevicesOfficial Action Indicated (OAI)3006733253
Jun 7, 2012Shenzhen, ChinaDevicesVoluntary Action Indicated (VAI)3006733253

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K201468Pulse OximeterJan 25, 2021
K192343Patient MonitorDec 31, 2019
K172792Handheld Pulse Oximeter, Model SP-20Nov 13, 2018
K170047All-in-One Health Monitor, PC-303Sep 9, 2017
K150093Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N…Jun 3, 2015
K123711PATIENT MONITOROct 1, 2013
K120502PC-60NW FINGERTIP OXIMETERDec 7, 2012
K093016VITAL SIGNS MONITORMar 30, 2010
K082055MODEL PC-860 FETAL DOPPLERFeb 6, 2009
K073152PC-180 / PRINCE 180 EASY ECG MONITORJan 10, 2008
K063641PC-60, NON-INVASIVEPULSE OXIMETERJul 13, 2007