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FDA 510(k)

THE DOME GX4MP COLOR NONITOR

K-Number: K120709 · 2012-04-06

ApplicantNds Surgical Imaging
Decision Date2012-04-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE DOME GX4MP COLOR NONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Nds Surgical Imaging. It received FDA 510(k) clearance on 2012-04-06 under 510(k) number K120709. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DOME GX4MP COLOR NONITOR?

THE DOME GX4MP COLOR NONITOR is a medical device that received FDA 510(k) clearance on 2012-04-06. The listed applicant is Nds Surgical Imaging. The 510(k) number is K120709.

When did THE DOME GX4MP COLOR NONITOR receive FDA 510(k) clearance?

THE DOME GX4MP COLOR NONITOR received FDA 510(k) clearance on 2012-04-06, under 510(k) number K120709.

Who is the listed applicant for THE DOME GX4MP COLOR NONITOR?

The FDA 510(k) record lists Nds Surgical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE DOME GX4MP COLOR NONITOR?

The FDA product code for THE DOME GX4MP COLOR NONITOR is LLZ.

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Other records listing Nds Surgical Imaging 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.

K131115ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIREK100195NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, XK080320PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300

Related Devices (Code: LLZ)

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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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