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FDA 510(k)

CONNECTED CARE CLINICAL APPLICATION

K-Number: K120320 · 2012-08-14

ApplicantWatermark Medical, Inc.
Decision Date2012-08-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONNECTED CARE CLINICAL APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Watermark Medical, Inc.. It received FDA 510(k) clearance on 2012-08-14 under 510(k) number K120320. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONNECTED CARE CLINICAL APPLICATION?

CONNECTED CARE CLINICAL APPLICATION is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Watermark Medical, Inc.. The 510(k) number is K120320.

When did CONNECTED CARE CLINICAL APPLICATION receive FDA 510(k) clearance?

CONNECTED CARE CLINICAL APPLICATION received FDA 510(k) clearance on 2012-08-14, under 510(k) number K120320.

Who is the listed applicant for CONNECTED CARE CLINICAL APPLICATION?

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

What is the FDA product code for CONNECTED CARE CLINICAL APPLICATION?

The FDA product code for CONNECTED CARE CLINICAL APPLICATION is DXN.

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Related Devices (Code: DXN)

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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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