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FDA 510(k)

myAblation Guide (VB80A)

K-Number: K240796 · 2024-08-06

Decision Date2024-08-06
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

myAblation Guide (VB80A) is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2024-08-06 under approval number K240796. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myAblation Guide (VB80A)?

myAblation Guide (VB80A) is a medical device that received FDA 510(k) clearance on 2024-08-06. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K240796.

When was myAblation Guide (VB80A) approved by the FDA?

myAblation Guide (VB80A) received FDA 510(k) clearance on 2024-08-06, under approval number K240796.

What company makes myAblation Guide (VB80A)?

myAblation Guide (VB80A) is manufactured by Siemens Healthcare GmbH.

What is the FDA product code for myAblation Guide (VB80A)?

The FDA product code for myAblation Guide (VB80A) is QTZ.

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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.