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FDA 510(k)

REAL Immersive System

K-Number: K183296 · 2019-03-18

ApplicantPenumbra, Inc.
Decision Date2019-03-18
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REAL Immersive System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2019-03-18 under approval number K183296. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL Immersive System?

REAL Immersive System is a medical device that received FDA 510(k) clearance on 2019-03-18. It is manufactured by Penumbra, Inc.. The 510(k) number is K183296.

When was REAL Immersive System approved by the FDA?

REAL Immersive System received FDA 510(k) clearance on 2019-03-18, under approval number K183296.

What company makes REAL Immersive System?

REAL Immersive System is manufactured by Penumbra, Inc..

What is the FDA product code for REAL Immersive System?

The FDA product code for REAL Immersive System is ISD.

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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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