Interspec 2 MHZ, Transcranial Pulsed Wave Doppler
FDA 510(k) K900155 · Interspec, Inc.
510(k) numberK900155
Submission
- Device name
- Interspec 2 MHZ, Transcranial Pulsed Wave Doppler
- Applicant
- Interspec, Inc.
Ambler, PA, US - Received
- January 12, 1990
- Decision date
- October 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K890173 | Interspec ApogeeIYO · Traditional | 04/14/1989SE |
| K863372 | SM-20 Cardioscan Doppler Option with CFM700 ProbesDPT · Traditional | 11/04/1986SE |
Questions and answers
When was Interspec 2 MHZ, Transcranial Pulsed Wave Doppler cleared by the FDA?
Interspec 2 MHZ, Transcranial Pulsed Wave Doppler (K900155) received a 510(k) decision of Substantially Equivalent on October 5, 1990, 266 days after the submission was received.
What is the product code of K900155?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.