Critical Care Suite
K-Number: K183182 · 2019-08-12
ApplicantGe Medical Systems, LLC
Decision Date2019-08-12
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Critical Care Suite is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2019-08-12 under approval number K183182. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Critical Care Suite?
Critical Care Suite is a medical device that received FDA 510(k) clearance on 2019-08-12. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K183182.
When was Critical Care Suite approved by the FDA?
Critical Care Suite received FDA 510(k) clearance on 2019-08-12, under approval number K183182.
What company makes Critical Care Suite?
Critical Care Suite is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for Critical Care Suite?
The FDA product code for Critical Care Suite is QFM.
Other Devices by Ge Medical Systems, LLC
Related Devices (Code: QFM)
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.