FDA.reportPublic FDA data

APK

Primary DI
06946725527863
Brand
APK
Company
APK Technology Co.,Ltd.
Model
A1414-SP203PU
Device description
Nonin Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
Published
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082846000APK SPO2 PULSE OXIMETER SENSORAPK Technology Co., Ltd.2009-04-03DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725527863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725527863069467255278636946725527863

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeter probe, reusableA photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529691989
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946725549926APKI-A0212-SY125PUA0212-SY125PU2026-03-19
06946725549933APKI-A0212-SA126PVA0212-SA126PV2026-03-19
06946725549940APKI-A0212-SA126PUA0212-SA126PU2026-03-19
06946725549919APKI-A0212-SI125PUA0212-SI125PU2026-03-17
06946725513996APKI-A0212-SA203MVA0212-SA203MV2026-03-10
06946725514009APKI-A0212-SA203MUA0212-SA203MU2026-03-10
06946725514016APKI-A0212-SP203MVA0212-SP203MV2026-03-10
06946725514023APKI-A0212-SP203MUA0212-SP203MU2026-03-10
06946725514030APKI-A0212-SW203MUA0212-SW203MU2026-03-10
06946725514047APKI-A0212-SR203MUA0212-SR203MU2026-03-10
06946725514054APKI-A0212-SI203MUA0212-SI203MU2026-03-10
06946725514061APKI-A0212-SY203MUA0212-SY203MU2026-03-10
06946725514078APKI-A0220-SA125PVA0220-SA125PV2026-03-10
06946725514085APKI-A0220-SA125PUA0220-SA125PU2026-03-10
06946725514092APKI-A0220-SP125PVA0220-SP125PV2026-03-10
06946725514108APKI-A0220-SP125PUA0220-SP125PU2026-03-10
06946725514115APKI-A0220-SW125PUA0220-SW125PU2026-03-10
06946725514122APKI-A0220-SR125PUA0220-SR125PU2026-03-10
06946725514139APKI-A0220-SI125PUA0220-SI125PU2026-03-10
06946725514146APKI-A0220-SY125PUA0220-SY125PU2026-03-10

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
06946725513620APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513637APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513644APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513651APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513668APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513675APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513682APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513699APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513705APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513712APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513729APKAPK Technology Co.,Ltd.DQA2026-03-10
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