FDA 510(k)

RTHawk, HeartVista Cardiac Package

K-Number: K153740 · 2016-06-30

Decision Date2016-06-30

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RTHawk, HeartVista Cardiac Package is a medical device manufactured by Heartvista, Inc.. It received FDA 510(k) clearance on 2016-06-30 under approval number K153740. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTHawk, HeartVista Cardiac Package?

RTHawk, HeartVista Cardiac Package is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Heartvista, Inc.. The 510(k) number is K153740.

When was RTHawk, HeartVista Cardiac Package approved by the FDA?

RTHawk, HeartVista Cardiac Package received FDA 510(k) clearance on 2016-06-30, under approval number K153740.

What company makes RTHawk, HeartVista Cardiac Package?

RTHawk, HeartVista Cardiac Package is manufactured by Heartvista, Inc..

What is the FDA product code for RTHawk, HeartVista Cardiac Package?

The FDA product code for RTHawk, HeartVista Cardiac Package is LNH.

Other Devices by Heartvista, Inc.

K170090RTHawk, HeartVista Cardiac Package K183274RTHawk, HeartVista Cardiac Package K212233RTHawk, HeartVista Cardiac Package

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Official Source

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