Name: Predicase
Price: 199 USD

K-number	K223127
Device name	HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Applicant	Edwards Lifeciences, LLC
Product code	DQK
Device class	Class II
Decision date	Nov 7, 2022
Decision	Substantially Equivalent
Regulation	870.1425

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

Everything you need for a 510(k) submission. Nothing you don't.