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FDA 510(k)

PhysCade System

K-Number: K250749 · 2025-06-04

ApplicantPhyscade, Inc.
Decision Date2025-06-04
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PhysCade System is a medical device manufactured by Physcade, Inc.. It received FDA 510(k) clearance on 2025-06-04 under approval number K250749. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhysCade System?

PhysCade System is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Physcade, Inc.. The 510(k) number is K250749.

When was PhysCade System approved by the FDA?

PhysCade System received FDA 510(k) clearance on 2025-06-04, under approval number K250749.

What company makes PhysCade System?

PhysCade System is manufactured by Physcade, Inc..

What is the FDA product code for PhysCade System?

The FDA product code for PhysCade System is DQK.

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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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