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FDA 510(k)

DIGNITY 100

K-Number: K082246 · 2008-09-09

ApplicantDignity Medical Devices, Inc.
Decision Date2008-09-09
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DIGNITY 100 is the device name listed in this FDA 510(k) record. The listed applicant is Dignity Medical Devices, Inc.. It received FDA 510(k) clearance on 2008-09-09 under 510(k) number K082246. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGNITY 100?

DIGNITY 100 is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Dignity Medical Devices, Inc.. The 510(k) number is K082246.

When did DIGNITY 100 receive FDA 510(k) clearance?

DIGNITY 100 received FDA 510(k) clearance on 2008-09-09, under 510(k) number K082246.

Who is the listed applicant for DIGNITY 100?

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

What is the FDA product code for DIGNITY 100?

The FDA product code for DIGNITY 100 is IOR.

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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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