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FDA 510(k)

Veraview X800

K-Number: K171012 · 2017-12-19

ApplicantJ. Morita USA, Inc.
Decision Date2017-12-19
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Veraview X800 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K171012. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Veraview X800?

Veraview X800 is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K171012.

When did Veraview X800 receive FDA 510(k) clearance?

Veraview X800 received FDA 510(k) clearance on 2017-12-19, under 510(k) number K171012.

Who is the listed applicant for Veraview X800?

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

What is the FDA product code for Veraview X800?

The FDA product code for Veraview X800 is OAS.

Other records listing J. Morita USA, 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.

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Related Devices (Code: OAS)

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.

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Official Source

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