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FDA 510(k)

FILMSAVER, NT VERSION 5.03

K-Number: K021072 · 2002-06-06

ApplicantAmerican Medical Resources, Ltd. (Amr)
Decision Date2002-06-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FILMSAVER, NT VERSION 5.03 is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Resources, Ltd. (Amr). It received FDA 510(k) clearance on 2002-06-06 under 510(k) number K021072. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILMSAVER, NT VERSION 5.03?

FILMSAVER, NT VERSION 5.03 is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is American Medical Resources, Ltd. (Amr). The 510(k) number is K021072.

When did FILMSAVER, NT VERSION 5.03 receive FDA 510(k) clearance?

FILMSAVER, NT VERSION 5.03 received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021072.

Who is the listed applicant for FILMSAVER, NT VERSION 5.03?

The FDA 510(k) record lists American Medical Resources, Ltd. (Amr) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILMSAVER, NT VERSION 5.03?

The FDA product code for FILMSAVER, NT VERSION 5.03 is LLZ.

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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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