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FDA 510(k)

ONDEMAND3D

K-Number: K113543 · 2011-12-16

ApplicantCybermed, Inc.
Decision Date2011-12-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONDEMAND3D is the device name listed in this FDA 510(k) record. The listed applicant is Cybermed, Inc.. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K113543. 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 ONDEMAND3D?

ONDEMAND3D is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Cybermed, Inc.. The 510(k) number is K113543.

When did ONDEMAND3D receive FDA 510(k) clearance?

ONDEMAND3D received FDA 510(k) clearance on 2011-12-16, under 510(k) number K113543.

Who is the listed applicant for ONDEMAND3D?

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

What is the FDA product code for ONDEMAND3D?

The FDA product code for ONDEMAND3D is LLZ.

Related Clinical Trials

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Other records listing Cybermed, 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.

K210039CORE1 Implant SystemK070464ONDEMAND3DK061126ACCUREXK053155VIMPLANTK013878CYBERMED, INC., V-WORKS

Related Devices (Code: LLZ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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