FDA.reportPublic FDA data

APK

Primary DI
06946725538289
Brand
APK
Company
APK Technology Co.,Ltd.
Model
S310-910
Device description
Philips Compatible Neonate SpO2 Sensor
Published
2023-11-15
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

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
06946725538289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725538289069467255382896946725538289

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, reprocessedA photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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
06946725572900APKS410S-0302026-10-26
06946725572924APKPH-9898031720312026-10-26
06946725572931APKSL-700-0008-882026-10-26
06946725572948APKDTG-MAXN2026-10-26
06946725516188APKI-A0424-SP101PUA0424-SP101PU2026-03-11
06946725516195APKI-A0424-SW101PUA0424-SW101PU2026-03-11
06946725516201APKI-A0424-SR101PUA0424-SR101PU2026-03-11
06946725516218APKI-A0424-SI101PUA0424-SI101PU2026-03-11
06946725516225APKI-A0424-SY101PUA0424-SY101PU2026-03-11
06946725516232APKI-A0424-SA203PVA0424-SA203PV2026-03-11
06946725516249APKI-A0424-SA203PUA0424-SA203PU2026-03-11
06946725516256APKI-A0424-SP203PVA0424-SP203PV2026-03-11
06946725516263APKI-A0424-SP203PUA0424-SP203PU2026-03-11
06946725516270APKI-A0424-SW203PUA0424-SW203PU2026-03-11
06946725516287APKI-A0424-SR203PUA0424-SR203PU2026-03-11
06946725516300APKI-A0424-SY203PUA0424-SY203PU2026-03-11
06946725516317APKI-A0412-SA108PVA0412-SA108PV2026-03-11
06946725516324APKI-A0412-SA108PUA0412-SA108PU2026-03-11
06946725516331APKI-A0412-SP108PVA0412-SP108PV2026-03-11
06946725516348APKI-A0412-SP108PUA0412-SP108PU2026-03-11

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
06946725516188APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516195APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516201APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516218APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516225APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516232APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516249APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516256APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516263APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516270APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516287APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516300APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516317APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516324APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516331APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516348APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516355APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516362APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516379APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516386APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516393APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516409APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516416APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516423APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516430APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516447APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516454APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516461APKAPK Technology Co.,Ltd.DQA2026-03-11