FDA.reportPublic FDA data

All-in-One Health Monitor

Primary DI
06941900603523
Brand
All-in-One Health Monitor
Company
Shenzhen Creative Industry Co., Ltd.
Model
PC-303
Published
2018-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DSHRecorder, Magnetic Tape, Medical
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170047000All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.2017-09-09MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941900603523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941900603523069419006035236941900603523

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analysis system, clinicalAn electrically-powered device assembly, possibly with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., noninvasive blood pressure (NIBP), pulse rate, temperature, and haemoglobin oxygen saturation (SpO2)] for intermittent spot-check measuring by a healthcare professional; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe). It may be attached to a wheeled stand or wall-mounted.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547908801
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941900601314Pulse OximeterKS-22024-12-27
06941900601321Pulse OximeterKS-60NW2024-12-27
06941900601338Pulse OximeterKS-60NWB2024-12-27
06941900601345Pulse OximeterS52024-12-27
06941900601352Pulse OximeterS5W2024-12-27
06941900601369Pulse OximeterS5B2024-12-27
06941900601376Pulse OximeterS5WB2024-12-27
06941900601383Pulse OximeterS5G2024-12-27
06941900601390Pulse OximeterS5WG2024-12-27
06941900601406Pulse OximeterKW-68B2024-12-27
06941900603394Pulse OximeterPC-66H2024-12-27
06941900604384Pulse OximeterPC-66L2024-12-27
06941900600492Pulse OximeterKS-60F2024-12-26
06941900600508Pulse OximeterKS-60FB2024-12-26
06941900600607Pulse OximeterKS-60FW2024-12-26
06941900600614Pulse OximeterKS-60FWB2024-12-26
06941900604407Pulse OximeterPC-60F2023-08-08
06941900604414Pulse OximeterPC-60FW2023-08-03
06941900603011Pulse OximeterPC-60A2020-05-28
06941900603240Pulse OximeterPC-60NW2020-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
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00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27