Infinity Acute Care System (IACS) Monitoring System
K-Number: K203088 · 2022-02-01
ApplicantDraeger Medical Systems, Inc.
Decision Date2022-02-01
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Infinity Acute Care System (IACS) Monitoring System is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-02-01 under approval number K203088. 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 System?
Infinity Acute Care System (IACS) Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-01. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K203088.
When was Infinity Acute Care System (IACS) Monitoring System approved by the FDA?
Infinity Acute Care System (IACS) Monitoring System received FDA 510(k) clearance on 2022-02-01, under approval number K203088.
What company makes Infinity Acute Care System (IACS) Monitoring System?
Infinity Acute Care System (IACS) Monitoring System is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for Infinity Acute Care System (IACS) Monitoring System?
The FDA product code for Infinity Acute Care System (IACS) Monitoring System 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.