COMMUNI-CALL— 510(k) K893473

Substantially Equivalent

Carepartners, Inc.

FDA 510(k) clearance K893473 for COMMUNI-CALL, Substantially Equivalent on 1989-06-09. Applicant: Carepartners, Inc..

Clearance details

Applicant
Carepartners, Inc.
Product code
Code ILQ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, D.C., DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ILQ

product code ILQ
Death
4
Malfunction
477
Total
481

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.