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FDA 510(k)

Healy

K-Number: K191075 · 2019-11-22

ApplicantTimewaver Production GmbH
Decision Date2019-11-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Healy is a medical device manufactured by Timewaver Production GmbH. It received FDA 510(k) clearance on 2019-11-22 under approval number K191075. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healy?

Healy is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Timewaver Production GmbH. The 510(k) number is K191075.

When was Healy approved by the FDA?

Healy received FDA 510(k) clearance on 2019-11-22, under approval number K191075.

What company makes Healy?

Healy is manufactured by Timewaver Production GmbH.

What is the FDA product code for Healy?

The FDA product code for Healy is NUH.

Other Devices by Timewaver Production GmbH

K212832TimeWaver Frequency

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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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