APELLO, PERSONAL HEALTH SUPPORT SYS.— 510(k) K831093

Substantially Equivalent

Almicro Electronics, Inc.

FDA 510(k) clearance K831093 for APELLO, PERSONAL HEALTH SUPPORT SYS., Substantially Equivalent on 1983-05-16. Applicant: Almicro Electronics, Inc..

Clearance details

Applicant
Almicro Electronics, Inc.
Product code
Code ILQ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, 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.