Infinity Acute Care System (IACS) Monitoring Solution
K-Number: K201764 · 2021-12-09
ApplicantDraeger Medical Systems, Inc.
Decision Date2021-12-09
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Infinity Acute Care System (IACS) Monitoring Solution is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-09 under approval number K201764. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infinity Acute Care System (IACS) Monitoring Solution?
Infinity Acute Care System (IACS) Monitoring Solution is a medical device that received FDA 510(k) clearance on 2021-12-09. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K201764.
When was Infinity Acute Care System (IACS) Monitoring Solution approved by the FDA?
Infinity Acute Care System (IACS) Monitoring Solution received FDA 510(k) clearance on 2021-12-09, under approval number K201764.
What company makes Infinity Acute Care System (IACS) Monitoring Solution?
Infinity Acute Care System (IACS) Monitoring Solution is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for Infinity Acute Care System (IACS) Monitoring Solution?
The FDA product code for Infinity Acute Care System (IACS) Monitoring Solution is MHX.
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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.