FDA 510(k)

FETOLY-HEART

K-Number: K241380 · 2024-09-11

Decision Date2024-09-11

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FETOLY-HEART is the device name listed in this FDA 510(k) record. The listed applicant is Diagnoly. It received FDA 510(k) clearance on 2024-09-11 under 510(k) 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. The listed applicant is Diagnoly. The 510(k) number is K241380.

When did FETOLY-HEART receive FDA 510(k) clearance?

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

Who is the listed applicant for FETOLY-HEART?

The FDA 510(k) record lists Diagnoly as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETOLY-HEART?

The FDA product code for FETOLY-HEART is IYN.

Other records listing Diagnoly as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251368FETOLY

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.