Identity
- Trade Name
- P8-3mTEE Ped Echocardiography Transducer FDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Model / Reference
- Z131-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415903787 FDA UDI
- 510(k) Number
- K171891 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Oesophageal ultrasound imaging transducer, reusable
P8-3mTEE Ped Echocardiography Transducer by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Oesophageal ultrasound imaging transducer, reusable.
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- MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER — Canon Medical Systems Corporation · Class II
- TEEx/8-3 MHz — Fujifilm Sonosite, Inc. · Class II
- Tee probe — CHISON Medical Technologies Co., Ltd. · Class II
- V5m Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
Cleared under the same submission
K171891 also covers:
- Aux CW, 2.0Mhz — Shenzhen Mindray Bio-Medical Electronics Co.
- Aux CW, 5.0Mhz — Shenzhen Mindray Bio-Medical Electronics Co.
- C18-5 Curved Array Tranducer — Shenzhen Mindray Bio-Medical Electronics Co.
- C18-5 Curved Array Tranducer 87555-00 — Shenzhen Mindray Bio-Medical Electronics Co.
- C6-1 Curved Array Tranducer 87777-00 — Shenzhen Mindray Bio-Medical Electronics Co.
- E9-3 Endocavitary Tranducer 87444-30 — Shenzhen Mindray Bio-Medical Electronics Co.
- E9-4 Ultrasonic Probe(FDA) 84002-40 — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module Kit(2147/AHA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Endocavity Transducer Holder Kit(ZS3) — Shenzhen Mindray Bio-Medical Electronics Co.
- P8-3TEE Echocardiography Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- P8-3mTEE Ped Echocardiography Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- SONY UP-D711MD Black &White Printer(KP+) — 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 c49f902d-800a-4dec-b257-c05376dbf81a 34 fields · synced May 30, 2026