Identity
- Trade Name
- Disposable SpO2 Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Model / Reference
- 520A-21-64100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904086712 FDA UDI
- 510(k) Number
- K182821 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulse oximeter probe, reusable
Disposable SpO2 Sensor by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, reusable.
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- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K182821 also covers:
- Fukuda Vital Signs Monitor — FUKUDA DENSHI USA, INC.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable child blood cuff(CM1502) — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable infant blood cuff (CM1501) — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable large adult blood cuff(CM1504) — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 51ce9247-7ca7-41d7-830e-191826e1a920 34 fields · synced May 30, 2026