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FDA 510(k)

DeepRhythm Platform

K-Number: K232161 · 2024-06-20

Decision Date2024-06-20
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DeepRhythm Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medicalgorithmics S.A.. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K232161. 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 DeepRhythm Platform?

DeepRhythm Platform is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Medicalgorithmics S.A.. The 510(k) number is K232161.

When did DeepRhythm Platform receive FDA 510(k) clearance?

DeepRhythm Platform received FDA 510(k) clearance on 2024-06-20, under 510(k) number K232161.

Who is the listed applicant for DeepRhythm Platform?

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

What is the FDA product code for DeepRhythm Platform?

The FDA product code for DeepRhythm Platform is DPS.

Other records listing Medicalgorithmics S.A. 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.

View all 8 devices →

Related Devices (Code: DPS)

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.

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.