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FDA 510(k)

PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300

K-Number: K080320 · 2008-02-21

ApplicantNds Surgical Imaging
Decision Date2008-02-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 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 2008-02-21 under 510(k) number K080320. 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 PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300?

PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Nds Surgical Imaging. The 510(k) number is K080320.

When did PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 receive FDA 510(k) clearance?

PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 received FDA 510(k) clearance on 2008-02-21, under 510(k) number K080320.

Who is the listed applicant for PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300?

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 PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300?

The FDA product code for PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 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 WIREK120709THE DOME GX4MP COLOR NONITORK100195NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X

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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