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FDA 510(k)

ROCC Console

K-Number: K242512 · 2024-10-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2024-10-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROCC Console is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K242512. 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 ROCC Console?

ROCC Console is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K242512.

When did ROCC Console receive FDA 510(k) clearance?

ROCC Console received FDA 510(k) clearance on 2024-10-24, under 510(k) number K242512.

Who is the listed applicant for ROCC Console?

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

What is the FDA product code for ROCC Console?

The FDA product code for ROCC Console is 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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