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FDA 510(k)

ULTRAVIEW DM3 MONITOR

K-Number: K093802 · 2010-04-09

ApplicantZoe Medical, Inc.
Decision Date2010-04-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRAVIEW DM3 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Zoe Medical, Inc.. It received FDA 510(k) clearance on 2010-04-09 under 510(k) number K093802. 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 ULTRAVIEW DM3 MONITOR?

ULTRAVIEW DM3 MONITOR is a medical device that received FDA 510(k) clearance on 2010-04-09. The listed applicant is Zoe Medical, Inc.. The 510(k) number is K093802.

When did ULTRAVIEW DM3 MONITOR receive FDA 510(k) clearance?

ULTRAVIEW DM3 MONITOR received FDA 510(k) clearance on 2010-04-09, under 510(k) number K093802.

Who is the listed applicant for ULTRAVIEW DM3 MONITOR?

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

What is the FDA product code for ULTRAVIEW DM3 MONITOR?

The FDA product code for ULTRAVIEW DM3 MONITOR is DXN.

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.

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Other records listing Zoe Medical, 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.

K200160740 SafeSATK130740NIGHTINGALE MONITORING SYSTEMK040012WELL@HOME SYSTEMK001775ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM

Related Devices (Code: DXN)

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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