MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T— 510(k) K904796
Substantially EquivalentPersonal Emergency Response System
FDA 510(k) clearance K904796 for MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T, Substantially Equivalent on 1990-11-26. Applicant: Personal Emergency Response System.
Clearance details
- Applicant
- Personal Emergency Response System
- Product code
- Code ILQ
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Longmeadow, MA, 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.