Cook-Swartz Doppler Flow Probe
FDA 510(k) K171272 · Cook Incorporated
510(k) numberK171272
Submission
- Device name
- Cook-Swartz Doppler Flow Probe
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- May 1, 2017
- Decision date
- July 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cook-Swartz Doppler Flow Probe cleared by the FDA?
Cook-Swartz Doppler Flow Probe (K171272) received a 510(k) decision of Substantially Equivalent on July 17, 2018, 442 days after the submission was received.
What is the product code of K171272?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.