Identity
- Trade Name
- Nihon Kohden FDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger FDA UDI
- Model / Reference
- A1411-SA116PV FDA UDI
- Description
- Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946725526552 FDA UDI
- 510(k) Number
- K172981 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse Co-oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse Co-oximeter probe, reusable
Nihon Kohden by Apk Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulse Co-oximeter probe, reusable.
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Cleared under the same submission
K172981 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Apk Technology
Sources (1)
- FDA UDI 39d5d7a9-eab2-41cd-a69a-564fd3bcdca1 34 fields · synced May 30, 2026