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FDA 510(k)

BRANSIST SAFIRE

K-Number: K062360 · 2006-10-05

ApplicantShimadzu Corp.
Decision Date2006-10-05
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRANSIST SAFIRE is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062360. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRANSIST SAFIRE?

BRANSIST SAFIRE is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Shimadzu Corp.. The 510(k) number is K062360.

When did BRANSIST SAFIRE receive FDA 510(k) clearance?

BRANSIST SAFIRE received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062360.

Who is the listed applicant for BRANSIST SAFIRE?

The FDA 510(k) record lists Shimadzu Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRANSIST SAFIRE?

The FDA product code for BRANSIST SAFIRE is IZI.

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Other records listing Shimadzu Corp. as applicant

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Related Devices (Code: IZI)

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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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