FDA 510(k)

AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12

K-Number: K033292 · 2003-11-26

Decision Date2003-11-26

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 is the device name listed in this FDA 510(k) record. The listed applicant is Igc-Medical Advances, Inc.. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K033292. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12?

AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Igc-Medical Advances, Inc.. The 510(k) number is K033292.

When did AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 receive FDA 510(k) clearance?

AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033292.

Who is the listed applicant for AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12?

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

What is the FDA product code for AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12?

The FDA product code for AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 is MOS.

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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.