FDA.reportPublic FDA data

APK

Primary DI
06946725550229
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-A0816-SP106MU
Catalog number
A0816-SP106MU
Device description
Philips / HP Compatible, Pediatric, Soft Tip
Published
2026-03-19
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
06946725550229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725550229069467255502296946725550229

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
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
06946725550236APKI-A0816-SR106MUA0816-SR106MU2026-03-19
06946725550243APKI-A0816-SI106MUA0816-SI106MU2026-03-19

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
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
06946725550359APKAPK Technology Co.,Ltd.DQA2026-03-19