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FDA 510(k)

DynaCAD

K-Number: K192200 · 2019-10-09

ApplicantInvivo Corporation
Decision Date2019-10-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DynaCAD is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K192200. 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 DynaCAD?

DynaCAD is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Invivo Corporation. The 510(k) number is K192200.

When did DynaCAD receive FDA 510(k) clearance?

DynaCAD received FDA 510(k) clearance on 2019-10-09, under 510(k) number K192200.

Who is the listed applicant for DynaCAD?

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

What is the FDA product code for DynaCAD?

The FDA product code for DynaCAD is LLZ.

Other records listing Invivo Corporation as applicant

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Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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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