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FDA 510(k)

TEMPEDY

K-Number: K152946 · 2016-09-15

ApplicantSeiratherm GmbH
Decision Date2016-09-15
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPEDY is a medical device manufactured by Seiratherm GmbH. It received FDA 510(k) clearance on 2016-09-15 under approval number K152946. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPEDY?

TEMPEDY is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Seiratherm GmbH. The 510(k) number is K152946.

When was TEMPEDY approved by the FDA?

TEMPEDY received FDA 510(k) clearance on 2016-09-15, under approval number K152946.

What company makes TEMPEDY?

TEMPEDY is manufactured by Seiratherm GmbH.

What is the FDA product code for TEMPEDY?

The FDA product code for TEMPEDY is NCX.

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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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