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FDA 510(k)

MLC FIT

K-Number: K991133 · 2000-03-27

ApplicantImpac Medical Systems, Inc.
Decision Date2000-03-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MLC FIT is the device name listed in this FDA 510(k) record. The listed applicant is Impac Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-03-27 under 510(k) number K991133. 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 MLC FIT?

MLC FIT is a medical device that received FDA 510(k) clearance on 2000-03-27. The listed applicant is Impac Medical Systems, Inc.. The 510(k) number is K991133.

When did MLC FIT receive FDA 510(k) clearance?

MLC FIT received FDA 510(k) clearance on 2000-03-27, under 510(k) number K991133.

Who is the listed applicant for MLC FIT?

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

What is the FDA product code for MLC FIT?

The FDA product code for MLC FIT is IYE.

Other records listing Impac Medical Systems, Inc. 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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