K231818
- 510(k) number
- K231818
- Device name
- METIC- Airway Balloon Catheter
- Applicant
- M/S Meril Life Sciences Pvt. , Ltd. IN
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2023-11-15
- Date received
- 2023-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231818.pdf
Official FDA record: K231818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.