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FDA 510(k)

MFM-CMS CENTRAL MONITORING SYSTEM

K-Number: K120727 · 2013-06-21

Decision Date2013-06-21
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MFM-CMS CENTRAL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2013-06-21 under 510(k) number K120727. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MFM-CMS CENTRAL MONITORING SYSTEM?

MFM-CMS CENTRAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K120727.

When did MFM-CMS CENTRAL MONITORING SYSTEM receive FDA 510(k) clearance?

MFM-CMS CENTRAL MONITORING SYSTEM received FDA 510(k) clearance on 2013-06-21, under 510(k) number K120727.

Who is the listed applicant for MFM-CMS CENTRAL MONITORING SYSTEM?

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

What is the FDA product code for MFM-CMS CENTRAL MONITORING SYSTEM?

The FDA product code for MFM-CMS CENTRAL MONITORING SYSTEM is MHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Edan Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 86 devices →

Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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