FDA 510(k)

DELPHI System

K-Number: K242907 · 2025-06-06

Decision Date2025-06-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DELPHI System is a medical device manufactured by CnS Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under approval 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. It is manufactured by CnS Medical Co., Ltd.. The 510(k) number is K242907.

When was DELPHI System approved by the FDA?

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

What company makes DELPHI System?

DELPHI System is manufactured by CnS Medical Co., Ltd..

What is the FDA product code for DELPHI System?

The FDA product code for DELPHI System is GEI.

Related PubMed Literature

PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

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Official Source

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