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FDA 510(k)

Desara TV, Desara Blue TV

K-Number: K162201 · 2017-01-11

ApplicantCaldera Medical, Inc.
Decision Date2017-01-11
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Desara TV, Desara Blue TV is a medical device manufactured by Caldera Medical, Inc.. It received FDA 510(k) clearance on 2017-01-11 under approval number K162201. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Desara TV, Desara Blue TV?

Desara TV, Desara Blue TV is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Caldera Medical, Inc.. The 510(k) number is K162201.

When was Desara TV, Desara Blue TV approved by the FDA?

Desara TV, Desara Blue TV received FDA 510(k) clearance on 2017-01-11, under approval number K162201.

What company makes Desara TV, Desara Blue TV?

Desara TV, Desara Blue TV is manufactured by Caldera Medical, Inc..

What is the FDA product code for Desara TV, Desara Blue TV?

The FDA product code for Desara TV, Desara Blue TV is OTN.

Other Devices by Caldera Medical, Inc.

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Related Devices (Code: OTN)

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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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