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FDA 510(k)

Thoracic VCAR with GSI Pulmonary Perfusion

K-Number: K183210 · 2019-03-29

ApplicantGE Medical Systems SCS
Decision Date2019-03-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Thoracic VCAR with GSI Pulmonary Perfusion is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K183210. 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 Thoracic VCAR with GSI Pulmonary Perfusion?

Thoracic VCAR with GSI Pulmonary Perfusion is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is GE Medical Systems SCS. The 510(k) number is K183210.

When did Thoracic VCAR with GSI Pulmonary Perfusion receive FDA 510(k) clearance?

Thoracic VCAR with GSI Pulmonary Perfusion received FDA 510(k) clearance on 2019-03-29, under 510(k) number K183210.

Who is the listed applicant for Thoracic VCAR with GSI Pulmonary Perfusion?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thoracic VCAR with GSI Pulmonary Perfusion?

The FDA product code for Thoracic VCAR with GSI Pulmonary Perfusion is LLZ.

Related Clinical Trials

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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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