FDA 510(k)

MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)

K-Number: K884913 · 1989-04-18

Decision Date1989-04-18

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) 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 1989-04-18 under 510(k) number K884913. 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 MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)?

MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) is a medical device that received FDA 510(k) clearance on 1989-04-18. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K884913.

When did MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) receive FDA 510(k) clearance?

MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) received FDA 510(k) clearance on 1989-04-18, under 510(k) number K884913.

Who is the listed applicant for MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)?

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 MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)?

The FDA product code for MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) is DXT.

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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.