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FDA 510(k)

INAREX, MODEL 2D-LX

K-Number: K080554 · 2008-08-27

ApplicantInarex Corporation
Decision Date2008-08-27
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INAREX, MODEL 2D-LX is the device name listed in this FDA 510(k) record. The listed applicant is Inarex Corporation. It received FDA 510(k) clearance on 2008-08-27 under 510(k) number K080554. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INAREX, MODEL 2D-LX?

INAREX, MODEL 2D-LX is a medical device that received FDA 510(k) clearance on 2008-08-27. The listed applicant is Inarex Corporation. The 510(k) number is K080554.

When did INAREX, MODEL 2D-LX receive FDA 510(k) clearance?

INAREX, MODEL 2D-LX received FDA 510(k) clearance on 2008-08-27, under 510(k) number K080554.

Who is the listed applicant for INAREX, MODEL 2D-LX?

The FDA 510(k) record lists Inarex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INAREX, MODEL 2D-LX?

The FDA product code for INAREX, MODEL 2D-LX is JFB.

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Other records listing Inarex Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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