The 5000 Compact Series Ultrasound Systems
K-Number: K242800 · 2024-11-15
ApplicantPhilips Ultrasound, LLC
Decision Date2024-11-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
The 5000 Compact Series Ultrasound Systems is a medical device manufactured by Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2024-11-15 under approval number K242800. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The 5000 Compact Series Ultrasound Systems?
The 5000 Compact Series Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Philips Ultrasound, LLC. The 510(k) number is K242800.
When was The 5000 Compact Series Ultrasound Systems approved by the FDA?
The 5000 Compact Series Ultrasound Systems received FDA 510(k) clearance on 2024-11-15, under approval number K242800.
What company makes The 5000 Compact Series Ultrasound Systems?
The 5000 Compact Series Ultrasound Systems is manufactured by Philips Ultrasound, LLC.
What is the FDA product code for The 5000 Compact Series Ultrasound Systems?
The FDA product code for The 5000 Compact Series Ultrasound Systems is IYN.
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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.