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FDA 510(k)

DISC-FX SYSTEM

K-Number: K052241 · 2006-02-24

ApplicantEllman International, Inc.
Decision Date2006-02-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISC-FX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ellman International, Inc.. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K052241. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISC-FX SYSTEM?

DISC-FX SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Ellman International, Inc.. The 510(k) number is K052241.

When did DISC-FX SYSTEM receive FDA 510(k) clearance?

DISC-FX SYSTEM received FDA 510(k) clearance on 2006-02-24, under 510(k) number K052241.

Who is the listed applicant for DISC-FX SYSTEM?

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

What is the FDA product code for DISC-FX SYSTEM?

The FDA product code for DISC-FX SYSTEM is HRX.

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Other records listing Ellman International, Inc. as applicant

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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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