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FDA 510(k)

PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240

K-Number: K040958 · 2005-02-15

ApplicantTokyo Boeki Medical System , Ltd.
Decision Date2005-02-15
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 is the device name listed in this FDA 510(k) record. The listed applicant is Tokyo Boeki Medical System , Ltd.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K040958. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240?

PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Tokyo Boeki Medical System , Ltd.. The 510(k) number is K040958.

When did PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 receive FDA 510(k) clearance?

PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 received FDA 510(k) clearance on 2005-02-15, under 510(k) number K040958.

Who is the listed applicant for PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240?

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

What is the FDA product code for PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240?

The FDA product code for PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 is JJE.

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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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