Identity
- Trade Name
- 75L38EB Ultrasonic Transducer(FDA) FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- PL1A-30-90476 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904088723 FDA UDI
- 510(k) Number
- K130833 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held 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: Extracorporeal ultrasound imaging transducer, hand-held
75L38EB Ultrasonic Transducer(FDA) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130833 also covers:
- 35C50EB Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DP-20/30 Double probe port module — Shenzhen Mindray Bio-Medical Electronics Co.
- UMT-110 Mobile Trolley — Shenzhen Mindray Bio-Medical Electronics Co.
- XDUCER ENDOCAVITY, 65EC10EB, FDA — Shenzhen Mindray Bio-Medical Electronics Co.
- lithium-ion Battery Pack — 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 65af2774-2b1f-4931-8a52-84ca85e7a4d9 34 fields · synced Jun 8, 2026