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FDA 510(k)

4CH FLEX SPEEDER

K-Number: K112366 · 2011-09-15

ApplicantToshiba Medical Systems Coporation, Japan
Decision Date2011-09-15
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4CH FLEX SPEEDER is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Coporation, Japan. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K112366. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4CH FLEX SPEEDER?

4CH FLEX SPEEDER is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Toshiba Medical Systems Coporation, Japan. The 510(k) number is K112366.

When did 4CH FLEX SPEEDER receive FDA 510(k) clearance?

4CH FLEX SPEEDER received FDA 510(k) clearance on 2011-09-15, under 510(k) number K112366.

Who is the listed applicant for 4CH FLEX SPEEDER?

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

What is the FDA product code for 4CH FLEX SPEEDER?

The FDA product code for 4CH FLEX SPEEDER is MOS.

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Other records listing Toshiba Medical Systems Coporation, Japan 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.

K121422APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEMK113466AQUILION ONEK110785KALARE DIAGNOSTIC X-RAY TABLE SYSTEMK1112514CH FLEX SPEEDER

Related Devices (Code: MOS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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