K230483
- 510(k) number
- K230483
- Device name
- Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
- Applicant
- Passy-Muir, Inc. CA · US
- Product code
- CAH — Filter, Bacterial, Breathing-Circuit
- Decision date
- 2023-09-16
- Date received
- 2023-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K230483.pdf
Official FDA record: K230483
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.