Identity
- Trade Name
- ST3 Digital Transcrannial Doppler System FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- PMD150 Unilateral Digital Transcranial Doppler FDA UDI
- Model / Reference
- PMD150U FDA UDI
- Description
- PMD150 Unilateral Digital Transcranial Doppler FDA UDI
Identifiers
- Catalog Number
- 11983 FDA UDI
- Primary DI / UDI-DI
- 00862726000302 FDA UDI
- 510(k) Number
- K002533 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 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
Category: Noninvasive vascular ultrasound system, line-powered
ST3 Digital Transcrannial Doppler System by Spencer Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002533 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
- Spencer Technologies
Sources (1)
- FDA UDI 942b934a-4e19-421a-9ea1-071495102d35 36 fields · synced Jun 8, 2026