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FDA 510(k)

SMARTSPOT PRIMAX

K-Number: K080890 · 2008-04-29

ApplicantCmt Medical Technologies, Ltd.
Decision Date2008-04-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMARTSPOT PRIMAX is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2008-04-29 under 510(k) number K080890. 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 SMARTSPOT PRIMAX?

SMARTSPOT PRIMAX is a medical device that received FDA 510(k) clearance on 2008-04-29. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K080890.

When did SMARTSPOT PRIMAX receive FDA 510(k) clearance?

SMARTSPOT PRIMAX received FDA 510(k) clearance on 2008-04-29, under 510(k) number K080890.

Who is the listed applicant for SMARTSPOT PRIMAX?

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

What is the FDA product code for SMARTSPOT PRIMAX?

The FDA product code for SMARTSPOT PRIMAX is 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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