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FDA 510(k)

DELPHI System

K-Number: K242907 · 2025-06-06

ApplicantCnS Medical Co., Ltd.
Decision Date2025-06-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DELPHI System is the device name listed in this FDA 510(k) record. The listed applicant is CnS Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242907. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELPHI System?

DELPHI System is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is CnS Medical Co., Ltd.. The 510(k) number is K242907.

When did DELPHI System receive FDA 510(k) clearance?

DELPHI System received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242907.

Who is the listed applicant for DELPHI System?

The FDA 510(k) record lists CnS Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELPHI System?

The FDA product code for DELPHI System is GEI.

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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.

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