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FDA 510(k)

Philips Biosensor BX100

K-Number: K192875 · 2020-04-16

ApplicantPhilips Medical Systems
Decision Date2020-04-16
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Philips Biosensor BX100 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K192875. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips Biosensor BX100?

Philips Biosensor BX100 is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Philips Medical Systems. The 510(k) number is K192875.

When did Philips Biosensor BX100 receive FDA 510(k) clearance?

Philips Biosensor BX100 received FDA 510(k) clearance on 2020-04-16, under 510(k) number K192875.

Who is the listed applicant for Philips Biosensor BX100?

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

What is the FDA product code for Philips Biosensor BX100?

The FDA product code for Philips Biosensor BX100 is DRG.

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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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