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FDA 510(k)

MIM - SPECTRA Quant

K-Number: K180815 · 2018-06-22

ApplicantMim Software, Inc.
Decision Date2018-06-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MIM - SPECTRA Quant is the device name listed in this FDA 510(k) record. The listed applicant is Mim Software, Inc.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180815. 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 MIM - SPECTRA Quant?

MIM - SPECTRA Quant is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Mim Software, Inc.. The 510(k) number is K180815.

When did MIM - SPECTRA Quant receive FDA 510(k) clearance?

MIM - SPECTRA Quant received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180815.

Who is the listed applicant for MIM - SPECTRA Quant?

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

What is the FDA product code for MIM - SPECTRA Quant?

The FDA product code for MIM - SPECTRA Quant is LLZ.

Other records listing Mim Software, Inc. as applicant

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Related Devices (Code: LLZ)

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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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