FDA 510(k)

FLUOROPLUA CARDIAC AND/OR INSTAVIEW

K-Number: K941917 · 1995-02-24

Decision Date1995-02-24

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FLUOROPLUA CARDIAC AND/OR INSTAVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Fidelity Medical, Inc.. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K941917. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROPLUA CARDIAC AND/OR INSTAVIEW?

FLUOROPLUA CARDIAC AND/OR INSTAVIEW is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Fidelity Medical, Inc.. The 510(k) number is K941917.

When did FLUOROPLUA CARDIAC AND/OR INSTAVIEW receive FDA 510(k) clearance?

FLUOROPLUA CARDIAC AND/OR INSTAVIEW received FDA 510(k) clearance on 1995-02-24, under 510(k) number K941917.

Who is the listed applicant for FLUOROPLUA CARDIAC AND/OR INSTAVIEW?

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

What is the FDA product code for FLUOROPLUA CARDIAC AND/OR INSTAVIEW?

The FDA product code for FLUOROPLUA CARDIAC AND/OR INSTAVIEW is JAA.

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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.