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ST3 Digital Transcrannial Doppler System

FDA UDI

Class II (US FDA UDI)

by Spencer Technologies

Identity

Trade Name
ST3 Digital Transcrannial Doppler System FDA UDI
Generic Name
Noninvasive vascular ultrasound system, line-powered FDA UDI
Device Name
PMD150 Bilateral Digital Transcranial Doppler FDA UDI
Model / Reference
PMD150B FDA UDI
Description
PMD150 Bilateral Digital Transcranial Doppler FDA UDI

Identifiers

Catalog Number
11894 FDA UDI
Primary DI / UDI-DI
00862726000319 FDA UDI
510(k) Number
K002533 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
GMDN Term
Noninvasive vascular ultrasound system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 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

Similar devices

Also classified as Noninvasive vascular ultrasound system, line-powered.

Cleared under the same submission

K002533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spencer Technologies

Sources (1)

  • FDA UDI dff1c6ba-195f-4a1c-aaf5-1e231e3fd84b 36 fields · synced May 30, 2026