The Vest Airway Clearance System— 510(k) K142482

Substantially Equivalent

Hill-Rom Services Private Limited

FDA 510(k) clearance K142482 for The Vest Airway Clearance System, Substantially Equivalent on 2015-05-07. Applicant: Hill-Rom Services Private Limited.

Clearance details

Applicant
Hill-Rom Services Private Limited
Product code
Code BYI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Singapore, SG
Download summary PDFView on FDA.gov ↗

Adverse events under product code BYI

product code BYI
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.