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FDA 510(k)

FETOLY-HEART

K-Number: K241380 · 2024-09-11

ApplicantDiagnoly
Decision Date2024-09-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FETOLY-HEART is a medical device manufactured by Diagnoly. It received FDA 510(k) clearance on 2024-09-11 under approval number K241380. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETOLY-HEART?

FETOLY-HEART is a medical device that received FDA 510(k) clearance on 2024-09-11. It is manufactured by Diagnoly. The 510(k) number is K241380.

When was FETOLY-HEART approved by the FDA?

FETOLY-HEART received FDA 510(k) clearance on 2024-09-11, under approval number K241380.

What company makes FETOLY-HEART?

FETOLY-HEART is manufactured by Diagnoly.

What is the FDA product code for FETOLY-HEART?

The FDA product code for FETOLY-HEART is IYN.

Other Devices by Diagnoly

K251368FETOLY

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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.

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