FDA.reportPublic FDA data

Handheld Pulse Oximeter

Primary DI
06941900604001
Brand
Handheld Pulse Oximeter
Company
Shenzhen Creative Industry Co., Ltd.
Model
SP-20
Published
2019-08-27
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
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172792000Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.2018-11-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941900604001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941900604001069419006040016941900604001

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

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

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
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
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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