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FDA 510(k)

Infinix INFX-8000V, V6.40

K-Number: K170909 · 2017-06-16

ApplicantToshiba Medical Systems Coroporation
Decision Date2017-06-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Infinix INFX-8000V, V6.40 is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Coroporation. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K170909. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinix INFX-8000V, V6.40?

Infinix INFX-8000V, V6.40 is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Toshiba Medical Systems Coroporation. The 510(k) number is K170909.

When did Infinix INFX-8000V, V6.40 receive FDA 510(k) clearance?

Infinix INFX-8000V, V6.40 received FDA 510(k) clearance on 2017-06-16, under 510(k) number K170909.

Who is the listed applicant for Infinix INFX-8000V, V6.40?

The FDA 510(k) record lists Toshiba Medical Systems Coroporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinix INFX-8000V, V6.40?

The FDA product code for Infinix INFX-8000V, V6.40 is OWB.

Other records listing Toshiba Medical Systems Coroporation 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.

K172188Aquilion Prime SP, TSX-303B/1, v8.4

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Official Source

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