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FDA 510(k)

Cook-Swartz Doppler Flow Probe

K-Number: K171272 · 2018-07-17

ApplicantCook Incorporated
Decision Date2018-07-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cook-Swartz Doppler Flow Probe is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-07-17 under 510(k) number K171272. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cook-Swartz Doppler Flow Probe?

Cook-Swartz Doppler Flow Probe is a medical device that received FDA 510(k) clearance on 2018-07-17. The listed applicant is Cook Incorporated. The 510(k) number is K171272.

When did Cook-Swartz Doppler Flow Probe receive FDA 510(k) clearance?

Cook-Swartz Doppler Flow Probe received FDA 510(k) clearance on 2018-07-17, under 510(k) number K171272.

Who is the listed applicant for Cook-Swartz Doppler Flow Probe?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cook-Swartz Doppler Flow Probe?

The FDA product code for Cook-Swartz Doppler Flow Probe is ITX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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