MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K-Number: K221321 · 2022-10-18
Decision Date2022-10-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2022-10-18 under approval number K221321. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System?
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System is a medical device that received FDA 510(k) clearance on 2022-10-18. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K221321.
When was MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System approved by the FDA?
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System received FDA 510(k) clearance on 2022-10-18, under approval number K221321.
What company makes MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System?
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System is manufactured by Ge Medical Systems Information Technologies, Inc..
What is the FDA product code for MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System?
The FDA product code for MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System is DPS.
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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.