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FDA 510(k)

IMSURE

K-Number: K031975 · 2003-08-29

ApplicantProdigm, Inc.
Decision Date2003-08-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMSURE is the device name listed in this FDA 510(k) record. The listed applicant is Prodigm, Inc.. It received FDA 510(k) clearance on 2003-08-29 under 510(k) number K031975. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMSURE?

IMSURE is a medical device that received FDA 510(k) clearance on 2003-08-29. The listed applicant is Prodigm, Inc.. The 510(k) number is K031975.

When did IMSURE receive FDA 510(k) clearance?

IMSURE received FDA 510(k) clearance on 2003-08-29, under 510(k) number K031975.

Who is the listed applicant for IMSURE?

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

What is the FDA product code for IMSURE?

The FDA product code for IMSURE is IYE.

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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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