FDA.reportPublic FDA data

APK

Primary DI
06946725517017
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-A1202-SI164PU
Catalog number
A1202-SI164PU
Device description
Edan Compatible, Infant, Soft Tip
Published
2026-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06946725517017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725517017069467255170176946725517017

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Regulatory Flags#

DUNS number
529691989
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946725516812APKI-A1202-SP125PVA1202-SP125PV2026-03-12
06946725516829APKI-A1202-SP125PUA1202-SP125PU2026-03-12
06946725516836APKI-A1202-SW125PUA1202-SW125PU2026-03-12
06946725516843APKI-A1202-SR125PUA1202-SR125PU2026-03-12
06946725516850APKI-A1202-SI125PUA1202-SI125PU2026-03-12
06946725516867APKI-A1202-SY125PUA1202-SY125PU2026-03-12
06946725516874APKI-A1202-SA129PV01A1202-SA129PV012026-03-12
06946725516881APKI-A1202-SA129PU01A1202-SA129PU012026-03-12
06946725516898APKI-A1202-SP129PV01A1202-SP129PV012026-03-12
06946725516904APKI-A1202-SP129PU01A1202-SP129PU012026-03-12
06946725516911APKI-A1202-SW129PU01A1202-SW129PU012026-03-12
06946725516928APKI-A1202-SR129PU01A1202-SR129PU012026-03-12
06946725516935APKI-A1202-SI129PU01A1202-SI129PU012026-03-12
06946725516942APKI-A1202-SY129PU01A1202-SY129PU012026-03-12
06946725516959APKI-A1202-SA164PVA1202-SA164PV2026-03-12
06946725516966APKI-A1202-SA164PUA1202-SA164PU2026-03-12
06946725516973APKI-A1202-SP164PVA1202-SP164PV2026-03-12
06946725516980APKI-A1202-SP164PUA1202-SP164PU2026-03-12
06946725516997APKI-A1202-SW164PUA1202-SW164PU2026-03-12
06946725517000APKI-A1202-SR164PUA1202-SR164PU2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725516812APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516829APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516836APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516843APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516850APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516867APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516874APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516881APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516898APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516904APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516911APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516928APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516935APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516942APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516959APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516966APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516973APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516980APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516997APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517000APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517024APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517031APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517048APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517055APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517062APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517079APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517086APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517093APKAPK Technology Co.,Ltd.DQA2026-03-12