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FDA 510(k)

CARDIMAX MODEL FX-2111

K-Number: K955416 · 1996-07-15

ApplicantFukuda Denshi USA, Inc.
Decision Date1996-07-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIMAX MODEL FX-2111 is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K955416. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIMAX MODEL FX-2111?

CARDIMAX MODEL FX-2111 is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K955416.

When did CARDIMAX MODEL FX-2111 receive FDA 510(k) clearance?

CARDIMAX MODEL FX-2111 received FDA 510(k) clearance on 1996-07-15, under 510(k) number K955416.

Who is the listed applicant for CARDIMAX MODEL FX-2111?

The FDA 510(k) record lists Fukuda Denshi USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIMAX MODEL FX-2111?

The FDA product code for CARDIMAX MODEL FX-2111 is DPS.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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Related Devices (Code: DPS)

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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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