Name: Predicase
Price: 199 USD

K-number	K231982
Device name	Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
Applicant	Qura S.R.L
Product code	DTZ
Device class	Class II
Decision date	Sep 12, 2024
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

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