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.. Device class: 2.

Clearance details

Applicant
Carepartners, Inc.
Product code
Code ILQ
Device class
Class 2
Regulation
21 CFR 890.3710
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 ↗

Recent devices under product code ILQ

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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.