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FDA 510(k)

ENSITE VERISMO SOFTWARE

K-Number: K051840 · 2005-08-15

ApplicantSt Jude Medical
Decision Date2005-08-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENSITE VERISMO SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2005-08-15 under 510(k) number K051840. 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 ENSITE VERISMO SOFTWARE?

ENSITE VERISMO SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-08-15. The listed applicant is St Jude Medical. The 510(k) number is K051840.

When did ENSITE VERISMO SOFTWARE receive FDA 510(k) clearance?

ENSITE VERISMO SOFTWARE received FDA 510(k) clearance on 2005-08-15, under 510(k) number K051840.

Who is the listed applicant for ENSITE VERISMO SOFTWARE?

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

What is the FDA product code for ENSITE VERISMO SOFTWARE?

The FDA product code for ENSITE VERISMO SOFTWARE is LLZ.

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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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