Name: Predicase
Price: 199 USD

K-number	K230483
Device name	Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Applicant	Passy-Muir, Inc.
Product code	CAH
Device class	Class II
Decision date	Sep 16, 2023
Decision	Substantially Equivalent
Regulation	868.5260

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Source

View the full FDA submission: accessdata.fda.gov

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Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

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