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FDA 510(k)

StentBoost Mobile

K-Number: K203623 · 2021-04-05

ApplicantPhilips India Limited
Decision Date2021-04-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

StentBoost Mobile is a medical device manufactured by Philips India Limited. It received FDA 510(k) clearance on 2021-04-05 under approval number K203623. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StentBoost Mobile?

StentBoost Mobile is a medical device that received FDA 510(k) clearance on 2021-04-05. It is manufactured by Philips India Limited. The 510(k) number is K203623.

When was StentBoost Mobile approved by the FDA?

StentBoost Mobile received FDA 510(k) clearance on 2021-04-05, under approval number K203623.

What company makes StentBoost Mobile?

StentBoost Mobile is manufactured by Philips India Limited.

What is the FDA product code for StentBoost Mobile?

The FDA product code for StentBoost Mobile is OWB.

Other Devices by Philips India Limited

K173187MobileDiagnost M50

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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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