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