Curbell branded Patient Monitoring Cables— 510(k) K182220

Substantially Equivalent

Curbell Medical Products, Inc.

FDA 510(k) clearance K182220 for Curbell branded Patient Monitoring Cables, Substantially Equivalent on 2018-11-07. Applicant: Curbell Medical Products, Inc..

Clearance details

Applicant
Curbell Medical Products, Inc.
Product code
Code DSA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Orchard Park, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DSA

product code DSA
Death
2
Total
2

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.