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FDA 510(k)

SUITEHEART

K-Number: K130228 · 2013-03-20

ApplicantNeosoft, LLC
Decision Date2013-03-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUITEHEART is the device name listed in this FDA 510(k) record. The listed applicant is Neosoft, LLC. It received FDA 510(k) clearance on 2013-03-20 under 510(k) number K130228. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUITEHEART?

SUITEHEART is a medical device that received FDA 510(k) clearance on 2013-03-20. The listed applicant is Neosoft, LLC. The 510(k) number is K130228.

When did SUITEHEART receive FDA 510(k) clearance?

SUITEHEART received FDA 510(k) clearance on 2013-03-20, under 510(k) number K130228.

Who is the listed applicant for SUITEHEART?

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

What is the FDA product code for SUITEHEART?

The FDA product code for SUITEHEART is LLZ.

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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.

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