Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ROCC Console

K-Number: K242512 · 2024-10-24

Decision Date2024-10-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROCC Console is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2024-10-24 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K242512.

When was ROCC Console approved by the FDA?

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

What company makes ROCC Console?

ROCC Console is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for ROCC Console?

The FDA product code for ROCC Console is LLZ.

Other Devices by Philips Medical Systems Nederland B.V.

View all 77 devices →

Related Devices (Code: LLZ)

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.