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FDA 510(k)

Desara TV, Desara Blue TV

K-Number: K162201 · 2017-01-11

Decision Date2017-01-11
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Desara TV, Desara Blue TV is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) 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. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K162201.

When did Desara TV, Desara Blue TV receive FDA 510(k) clearance?

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

Who is the listed applicant for Desara TV, Desara Blue TV?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Caldera Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 8 devices →

Related Devices (Code: OTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.