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FDA 510(k)

OCTAVE SPEEDER HEAD

K-Number: K121910 · 2012-08-17

ApplicantToshiba Medical Systems Corporation, Japan
Decision Date2012-08-17
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OCTAVE SPEEDER HEAD 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 2012-08-17 under 510(k) number K121910. 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 OCTAVE SPEEDER HEAD?

OCTAVE SPEEDER HEAD is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K121910.

When did OCTAVE SPEEDER HEAD receive FDA 510(k) clearance?

OCTAVE SPEEDER HEAD received FDA 510(k) clearance on 2012-08-17, under 510(k) number K121910.

Who is the listed applicant for OCTAVE SPEEDER HEAD?

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 OCTAVE SPEEDER HEAD?

The FDA product code for OCTAVE SPEEDER HEAD is MOS.

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Other records listing Toshiba Medical Systems Corporation, Japan as applicant

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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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