FDA 510(k)

MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)

K-Number: K973230 · 1997-11-25

Decision Date1997-11-25

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-11-25 under 510(k) number K973230. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)?

MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) is a medical device that received FDA 510(k) clearance on 1997-11-25. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K973230.

When did MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) receive FDA 510(k) clearance?

MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) received FDA 510(k) clearance on 1997-11-25, under 510(k) number K973230.

Who is the listed applicant for MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)?

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

What is the FDA product code for MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)?

The FDA product code for MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) is DXT.

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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.