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FDA 510(k)

INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V

K-Number: K112054 · 2011-08-05

ApplicantToshiba Medical Systems Corporation, Japan
Decision Date2011-08-05
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Corporation, Japan. It received FDA 510(k) clearance on 2011-08-05 under 510(k) number K112054. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V?

INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V is a medical device that received FDA 510(k) clearance on 2011-08-05. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K112054.

When did INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V receive FDA 510(k) clearance?

INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V received FDA 510(k) clearance on 2011-08-05, under 510(k) number K112054.

Who is the listed applicant for INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V?

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

What is the FDA product code for INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V?

The FDA product code for INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V is JAA.

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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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