Al-Rad Companion (Pulmonary)
K-Number: K213096 · 2021-12-06
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-12-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Al-Rad Companion (Pulmonary) is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-12-06 under approval number K213096. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Al-Rad Companion (Pulmonary)?
Al-Rad Companion (Pulmonary) is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K213096.
When was Al-Rad Companion (Pulmonary) approved by the FDA?
Al-Rad Companion (Pulmonary) received FDA 510(k) clearance on 2021-12-06, under approval number K213096.
What company makes Al-Rad Companion (Pulmonary)?
Al-Rad Companion (Pulmonary) is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Al-Rad Companion (Pulmonary)?
The FDA product code for Al-Rad Companion (Pulmonary) is JAK.
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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.