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FDA 510(k)

PRESTIGE 24I; BIOLIS 24I; MGC 240

K-Number: K103531 · 2011-12-01

ApplicantTokyo Boeki Medisys, Inc.
Decision Date2011-12-01
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRESTIGE 24I; BIOLIS 24I; MGC 240 is the device name listed in this FDA 510(k) record. The listed applicant is Tokyo Boeki Medisys, Inc.. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K103531. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESTIGE 24I; BIOLIS 24I; MGC 240?

PRESTIGE 24I; BIOLIS 24I; MGC 240 is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Tokyo Boeki Medisys, Inc.. The 510(k) number is K103531.

When did PRESTIGE 24I; BIOLIS 24I; MGC 240 receive FDA 510(k) clearance?

PRESTIGE 24I; BIOLIS 24I; MGC 240 received FDA 510(k) clearance on 2011-12-01, under 510(k) number K103531.

Who is the listed applicant for PRESTIGE 24I; BIOLIS 24I; MGC 240?

The FDA 510(k) record lists Tokyo Boeki Medisys, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESTIGE 24I; BIOLIS 24I; MGC 240?

The FDA product code for PRESTIGE 24I; BIOLIS 24I; MGC 240 is CFR.

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Other records listing Tokyo Boeki Medisys, Inc. as applicant

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Official Source

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