Identity
- Trade Name
- ScvO2 optical module FDA UDI
- Generic Name
- Patient monitoring system module, intracranial pressure FDA UDI
- Model / Reference
- 115-008191-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904036700 FDA UDI
- 510(k) Number
- K143195 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Patient monitoring system module, intracranial pressure FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, intracranial pressure
ScvO2 optical module by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ScvO2 function upgrade kit — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
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Cleared under the same submission
K143195 also covers:
- 12-Lead Leadset, Chest, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 12-Lead Leadset, Chest, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Cable, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Cable, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Host Cable, Def-P — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead Host Cable, Def-P, DIN Conn — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-LEAD, ECG, UNIV, SNAP, 18", USA — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-LEAD, ECG, UNIV, SNAP, 36", AAMI — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead Leadset, Adt/Ped, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead Leadset, Inf, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 24", AAMI — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 24", IEC — 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 48343fb9-5af0-4fc9-ac84-8fd51dc51d79 34 fields · synced Jun 6, 2026