FDA.reportPublic FDA data

Accurate®

Primary DI
06927394500081
Brand
Accurate®
Company
Hunan Accurate Bio-Medical Technology Co., Ltd.
Model
FS20E
Published
2018-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141105000PULSE OXIMETERHunan Accurate Bio-Medical Technology Co., Ltd.2014-12-04DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06927394500081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06927394500081069273945000816927394500081

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421349331
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06927394503211K-fitK-fit Pelflex PF012026-09-05
06927394502771Accurate®WS20E2026-02-02
06927394503051VirtuSleepVirtuSleep WS20A2025-10-31
06927394502474CONCORD750442024-10-11
06927394500999Accare®WS20A2023-11-06
06927394501583Accurate®WS20A2023-03-13
06927394501590Accurate®FS10M2023-03-13
06927394501606Accurate®FS20M2023-03-13
06927394511100Accurate®FS10K2023-03-13
06927394511117Accurate®FS20K2023-03-13
06927394511124Accurate®FS20I2023-03-13
06927394511131Accurate®FS10I2023-03-13
06927394511148Accurate®FS20P2023-03-13
06927394511162Accurate®FS20F 2023-03-13
06927394511179Accurate®FS10F 2023-03-10
06927394500180CONCORD750792021-08-27
06927394500104CONCORD75023R2021-03-12
06927394535557CONCORD750232019-09-30
06927394533348Accurate®HS10A2019-09-10
69273945000050Accurate®FS20C2018-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549919APKAPK Technology Co.,Ltd.DQA2026-03-17
06946725513606APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513613APKAPK Technology Co.,Ltd.DQA2026-03-10
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06946725513705APKAPK Technology Co.,Ltd.DQA2026-03-10
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06946725513736APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513743APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513767APKAPK Technology Co.,Ltd.DQA2026-03-10