Name: Predicase
Price: 199 USD

K-number	K223879
Device name	Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Applicant	Quara S.R.L.
Product code	DTR
Device class	Class II
Decision date	Apr 13, 2023
Decision	Substantially Equivalent
Regulation	870.4240

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)

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