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FDA 510(k)

MASTALEX -MRSA, MODEL RST501

K-Number: K062864 · 2006-10-18

ApplicantMast Group , Ltd.
Decision Date2006-10-18
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MASTALEX -MRSA, MODEL RST501 is the device name listed in this FDA 510(k) record. The listed applicant is Mast Group , Ltd.. It received FDA 510(k) clearance on 2006-10-18 under 510(k) number K062864. The device is classified under product code MYI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTALEX -MRSA, MODEL RST501?

MASTALEX -MRSA, MODEL RST501 is a medical device that received FDA 510(k) clearance on 2006-10-18. The listed applicant is Mast Group , Ltd.. The 510(k) number is K062864.

When did MASTALEX -MRSA, MODEL RST501 receive FDA 510(k) clearance?

MASTALEX -MRSA, MODEL RST501 received FDA 510(k) clearance on 2006-10-18, under 510(k) number K062864.

Who is the listed applicant for MASTALEX -MRSA, MODEL RST501?

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

What is the FDA product code for MASTALEX -MRSA, MODEL RST501?

The FDA product code for MASTALEX -MRSA, MODEL RST501 is MYI.

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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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