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FDA 510(k)

CLINICAL ALERT NOTIFICATION

K-Number: K130339 · 2013-07-11

ApplicantExtension , Inc.
Decision Date2013-07-11
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLINICAL ALERT NOTIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Extension , Inc.. It received FDA 510(k) clearance on 2013-07-11 under 510(k) number K130339. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL ALERT NOTIFICATION?

CLINICAL ALERT NOTIFICATION is a medical device that received FDA 510(k) clearance on 2013-07-11. The listed applicant is Extension , Inc.. The 510(k) number is K130339.

When did CLINICAL ALERT NOTIFICATION receive FDA 510(k) clearance?

CLINICAL ALERT NOTIFICATION received FDA 510(k) clearance on 2013-07-11, under 510(k) number K130339.

Who is the listed applicant for CLINICAL ALERT NOTIFICATION?

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

What is the FDA product code for CLINICAL ALERT NOTIFICATION?

The FDA product code for CLINICAL ALERT NOTIFICATION is MSX.

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Related Devices (Code: MSX)

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.

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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.

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