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FDA 510(k)

Neocis Planning Software Application (NPSA) for 3rd Party PCs

K-Number: K191363 · 2019-10-02

ApplicantNeocis, Inc.
Decision Date2019-10-02
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Planning Software Application (NPSA) for 3rd Party PCs is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191363. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neocis Planning Software Application (NPSA) for 3rd Party PCs?

Neocis Planning Software Application (NPSA) for 3rd Party PCs is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Neocis, Inc.. The 510(k) number is K191363.

When did Neocis Planning Software Application (NPSA) for 3rd Party PCs receive FDA 510(k) clearance?

Neocis Planning Software Application (NPSA) for 3rd Party PCs received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191363.

Who is the listed applicant for Neocis Planning Software Application (NPSA) for 3rd Party PCs?

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

What is the FDA product code for Neocis Planning Software Application (NPSA) for 3rd Party PCs?

The FDA product code for Neocis Planning Software Application (NPSA) for 3rd Party PCs is PLV.

Other records listing Neocis, 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.

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Related Devices (Code: PLV)

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.

K252376Yomi S Robotic SystemNeocis, Inc.K251835Yomi Robotic SystemNeocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi Robotic SystemNeocis, Inc.K210947NavidentClaronav, Inc.K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.

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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