Precision DL
K-Number: K223212 · 2023-04-27
ApplicantGE Healthcare
Decision Date2023-04-27
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Precision DL is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2023-04-27 under approval number K223212. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Precision DL?
Precision DL is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by GE Healthcare. The 510(k) number is K223212.
When was Precision DL approved by the FDA?
Precision DL received FDA 510(k) clearance on 2023-04-27, under approval number K223212.
What company makes Precision DL?
Precision DL is manufactured by GE Healthcare.
What is the FDA product code for Precision DL?
The FDA product code for Precision DL is KPS.
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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.