MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM— 510(k) K124000
Substantially EquivalentMedapps Inc., Dba Alere Connect
FDA 510(k) clearance K124000 for MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM, Substantially Equivalent on 2013-07-30. Applicant: Medapps Inc., Dba Alere Connect.
Clearance details
- Applicant
- Medapps Inc., Dba Alere Connect
- Product code
- Code DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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.