FDA.reportPublic FDA data

APK

Primary DI
06946725514016
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-A0212-SP203MV
Catalog number
A0212-SP203MV
Device description
Biolight Compatible, Pediatric, Finger Clip
Published
2026-03-10
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
06946725514016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725514016069467255140166946725514016

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
06946725549926APKI-A0212-SY125PUA0212-SY125PU2026-03-19
06946725549933APKI-A0212-SA126PVA0212-SA126PV2026-03-19
06946725549940APKI-A0212-SA126PUA0212-SA126PU2026-03-19
06946725549919APKI-A0212-SI125PUA0212-SI125PU2026-03-17
06946725513996APKI-A0212-SA203MVA0212-SA203MV2026-03-10
06946725514009APKI-A0212-SA203MUA0212-SA203MU2026-03-10
06946725514023APKI-A0212-SP203MUA0212-SP203MU2026-03-10
06946725514030APKI-A0212-SW203MUA0212-SW203MU2026-03-10
06946725514047APKI-A0212-SR203MUA0212-SR203MU2026-03-10
06946725514054APKI-A0212-SI203MUA0212-SI203MU2026-03-10
06946725514061APKI-A0212-SY203MUA0212-SY203MU2026-03-10
06946725514078APKI-A0220-SA125PVA0220-SA125PV2026-03-10
06946725514085APKI-A0220-SA125PUA0220-SA125PU2026-03-10
06946725514092APKI-A0220-SP125PVA0220-SP125PV2026-03-10
06946725514108APKI-A0220-SP125PUA0220-SP125PU2026-03-10
06946725514115APKI-A0220-SW125PUA0220-SW125PU2026-03-10
06946725514122APKI-A0220-SR125PUA0220-SR125PU2026-03-10
06946725514139APKI-A0220-SI125PUA0220-SI125PU2026-03-10
06946725514146APKI-A0220-SY125PUA0220-SY125PU2026-03-10
06946725514153APKI-A0212-SA125PVA0212-SA125PV2026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549919APKAPK Technology Co.,Ltd.DQA2026-03-17
06946725513606APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513613APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513620APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513637APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513644APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513651APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513668APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513675APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513682APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513699APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513705APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513712APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513729APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513736APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513743APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10