CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
K-Number: K230834 · 2023-11-21
ApplicantTrismed Co., Ltd.
Decision Date2023-11-21
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H is a medical device manufactured by Trismed Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under approval number K230834. 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 CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H?
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Trismed Co., Ltd.. The 510(k) number is K230834.
When was CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H approved by the FDA?
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H received FDA 510(k) clearance on 2023-11-21, under approval number K230834.
What company makes CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H?
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H is manufactured by Trismed Co., Ltd..
What is the FDA product code for CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H?
The FDA product code for CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H 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.