PERCUSSIVENEB, MODEL PN-2001— 510(k) K003684

Substantially Equivalent

Vortran Medical Technology 1, Inc.

FDA 510(k) clearance K003684 for PERCUSSIVENEB, MODEL PN-2001, Substantially Equivalent on 2001-02-23. Applicant: Vortran Medical Technology 1, Inc..

Clearance details

Applicant
Vortran Medical Technology 1, Inc.
Product code
Code NHJ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Sacramento, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NHJ

product code NHJ
Death
7
Total
7

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.