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FDA 510(k)

ASCOM CLINICALCONNEX CARDIOMAX

K-Number: K103634 · 2011-02-23

ApplicantAscom (Us), Inc.
Decision Date2011-02-23
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASCOM CLINICALCONNEX CARDIOMAX is the device name listed in this FDA 510(k) record. The listed applicant is Ascom (Us), Inc.. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K103634. 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 ASCOM CLINICALCONNEX CARDIOMAX?

ASCOM CLINICALCONNEX CARDIOMAX is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Ascom (Us), Inc.. The 510(k) number is K103634.

When did ASCOM CLINICALCONNEX CARDIOMAX receive FDA 510(k) clearance?

ASCOM CLINICALCONNEX CARDIOMAX received FDA 510(k) clearance on 2011-02-23, under 510(k) number K103634.

Who is the listed applicant for ASCOM CLINICALCONNEX CARDIOMAX?

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

What is the FDA product code for ASCOM CLINICALCONNEX CARDIOMAX?

The FDA product code for ASCOM CLINICALCONNEX CARDIOMAX is MSX.

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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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