FDA.reportPublic FDA data

APK

Primary DI
06946725526149
Brand
APK
Company
APK Technology Co.,Ltd.
Model
A1023-SP111PV
Device description
Goldway Compatible Reusable SpO2 Sensor
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06946725526149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725526149069467255261496946725526149

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
06946725550120APKI-A0816-SA106PUA0816-SA106PU2026-03-26
06946725550175APKI-A0816-SI106PUA0816-SI106PU2026-03-26
06946725550335APKI-A1023-SP125PVA1023-SP125PV2026-03-26
06946725550519APKI-A1902-SI135MUA1902-SI135MU2026-03-27
06946725550069APKI-A1501-SR203PUA1501-SR203PU2026-03-19
06946725550076APKI-A0816-SP105PUA0816-SP105PU2026-03-19
06946725550083APKI-A0816-SW105PUA0816-SW105PU2026-03-19
06946725550090APKI-A0816-SR105PUA0816-SR105PU2026-03-19
06946725550106APKI-A0816-SI105PUA0816-SI105PU2026-03-19
06946725550113APKI-A0816-SY105PUA0816-SY105PU2026-03-19
06946725550137APKI-A0816-SP106PVA0816-SP106PV2026-03-19
06946725550144APKI-A0816-SP106PUA0816-SP106PU2026-03-19
06946725550151APKI-A0816-SW106PUA0816-SW106PU2026-03-19
06946725550168APKI-A0816-SR106PUA0816-SR106PU2026-03-19
06946725550182APKI-A0816-SY106PUA0816-SY106PU2026-03-19
06946725550199APKI-A0816-SA106MVA0816-SA106MV2026-03-19
06946725550205APKI-A0816-SA106MUA0816-SA106MU2026-03-19
06946725550212APKI-A0816-SP106MVA0816-SP106MV2026-03-19
06946725550229APKI-A0816-SP106MUA0816-SP106MU2026-03-19
06946725550236APKI-A0816-SR106MUA0816-SR106MU2026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725550519APKAPK Technology Co.,Ltd.DQA2026-03-27
06946725550120APKAPK Technology Co.,Ltd.DQA2026-03-26
06946725550175APKAPK Technology Co.,Ltd.DQA2026-03-26
06946725550335APKAPK Technology Co.,Ltd.DQA2026-03-26
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550243APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550250APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550267APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550274APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550281APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550298APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550304APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550311APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550328APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550342APKAPK Technology Co.,Ltd.DQA2026-03-19