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FDA 510(k)

ECG CT Gating Device

K-Number: K160350 · 2016-06-16

ApplicantNeocoil, LLC
Decision Date2016-06-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECG CT Gating Device is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160350. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG CT Gating Device?

ECG CT Gating Device is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Neocoil, LLC. The 510(k) number is K160350.

When did ECG CT Gating Device receive FDA 510(k) clearance?

ECG CT Gating Device received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160350.

Who is the listed applicant for ECG CT Gating Device?

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

What is the FDA product code for ECG CT Gating Device?

The FDA product code for ECG CT Gating Device is JAK.

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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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