Spencer Technologies

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

ST3 Digital Transcrannial Doppler System - 00862726000302 Catalog Number : 11983

Device Description : PMD150 Unilateral Digital Transcranial Doppler

Device Class : 2

Duns Number: 933762262

Premarket Exempt : No

Product Code : ITX, IYN

Prescription Use : Yes

Device Count : 1

ST3 Digital Transcrannial Doppler System - 00862726000319 Catalog Number : 11894

Device Description : PMD150 Bilateral Digital Transcranial Doppler

Device Class : 2

Duns Number: 933762262

Premarket Exempt : No

Product Code : ITX, IYN

Prescription Use : Yes

Device Count : 1

PMD Viewer - 00862726000326 Catalog Number : 12143

Device Description : PMD Viewer Software

Device Class : 2

Duns Number: 933762262

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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