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FDA 510(k)

CMS-1000FM CENTRAL MONITORING SYSTEM

K-Number: K112159 · 2011-09-21

ApplicantAdvanced Instrumentations, Inc.
Decision Date2011-09-21
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CMS-1000FM CENTRAL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2011-09-21 under 510(k) number K112159. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMS-1000FM CENTRAL MONITORING SYSTEM?

CMS-1000FM CENTRAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-21. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K112159.

When did CMS-1000FM CENTRAL MONITORING SYSTEM receive FDA 510(k) clearance?

CMS-1000FM CENTRAL MONITORING SYSTEM received FDA 510(k) clearance on 2011-09-21, under 510(k) number K112159.

Who is the listed applicant for CMS-1000FM CENTRAL MONITORING SYSTEM?

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

What is the FDA product code for CMS-1000FM CENTRAL MONITORING SYSTEM?

The FDA product code for CMS-1000FM CENTRAL MONITORING SYSTEM is HGM.

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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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