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FDA 510(k)

MISER CONTRAST MANAGEMENT SYSTEM

K-Number: K083576 · 2008-12-23

ApplicantMerit Medical Systems, Inc.
Decision Date2008-12-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MISER CONTRAST MANAGEMENT SYSTEM 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 2008-12-23 under 510(k) number K083576. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISER CONTRAST MANAGEMENT SYSTEM?

MISER CONTRAST MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K083576.

When did MISER CONTRAST MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MISER CONTRAST MANAGEMENT SYSTEM received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083576.

Who is the listed applicant for MISER CONTRAST MANAGEMENT SYSTEM?

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 MISER CONTRAST MANAGEMENT SYSTEM?

The FDA product code for MISER CONTRAST MANAGEMENT SYSTEM is FPA.

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Related Devices (Code: FPA)

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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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