FDA.reportPublic FDA data

APK

Primary DI
06946725519219
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-A1411-SP116PV
Catalog number
A1411-SP116PV
Device description
Nihon Kohden Compatible, Pediatric, Finger Clip
Published
2026-03-13
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
K172981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172981000Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.2018-06-08DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725519219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725519219069467255192196946725519219

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
06946725550021APKI-A1424-SA203PUA1424-SA203PU2026-03-19
06946725550038APKI-A1424-SP203PVA1424-SP203PV2026-03-19
06946725550045APKI-A1424-SP203PUA1424-SP203PU2026-03-19
06946725519196APKI-A1411-SA116PVA1411-SA116PV2026-03-13
06946725519202APKI-A1411-SA116PUA1411-SA116PU2026-03-13
06946725519226APKI-A1411-SP116PUA1411-SP116PU2026-03-13
06946725519233APKI-A1411-SW116PUA1411-SW116PU2026-03-13
06946725519240APKI-A1411-SR116PUA1411-SR116PU2026-03-13
06946725519257APKI-A1411-SI116PUA1411-SI116PU2026-03-13
06946725519264APKI-A1411-SY116PUA1411-SY116PU2026-03-13
06946725519271APKI-A1411-SA136PVA1411-SA136PV2026-03-13
06946725519288APKI-A1411-SA136PUA1411-SA136PU2026-03-13
06946725519295APKI-A1411-SP136PVA1411-SP136PV2026-03-13
06946725519301APKI-A1411-SP136PUA1411-SP136PU2026-03-13
06946725519318APKI-A1411-SW136PUA1411-SW136PU2026-03-13
06946725519325APKI-A1411-SR136PUA1411-SR136PU2026-03-13
06946725519332APKI-A1411-SI136PUA1411-SI136PU2026-03-13
06946725519349APKI-A1411-SY136PUA1411-SY136PU2026-03-13
06946725519356APKI-A1411-SA136MVA1411-SA136MV2026-03-13
06946725519363APKI-A1411-SA136MUA1411-SA136MU2026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709121746MidmarkMIDMARK CORPORATIONDQA2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONDQA2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONDQA2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONDQA2026-10-30
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725519196APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519202APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519226APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519233APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519240APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519257APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519264APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519271APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519288APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519295APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519301APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519318APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519325APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519332APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519349APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519356APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519363APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519370APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519387APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519394APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519400APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519417APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519424APKAPK Technology Co.,Ltd.DQA2026-03-13