MAC 7 - Resting ECG Analysis System
K-Number: K203786 · 2021-04-30
Decision Date2021-04-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MAC 7 - Resting ECG Analysis System is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2021-04-30 under approval number K203786. 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 7 - Resting ECG Analysis System?
MAC 7 - Resting ECG Analysis System is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K203786.
When was MAC 7 - Resting ECG Analysis System approved by the FDA?
MAC 7 - Resting ECG Analysis System received FDA 510(k) clearance on 2021-04-30, under approval number K203786.
What company makes MAC 7 - Resting ECG Analysis System?
MAC 7 - Resting ECG Analysis System is manufactured by Ge Medical Systems Information Technologies, Inc..
What is the FDA product code for MAC 7 - Resting ECG Analysis System?
The FDA product code for MAC 7 - 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.