ELECTRONIC HOUSE CALL— 510(k) K090801
Substantially EquivalentExpress MD Solutions, LLC
FDA 510(k) clearance K090801 for ELECTRONIC HOUSE CALL, Substantially Equivalent on 2009-04-08. Applicant: Express MD Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Express MD Solutions, LLC
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code DRG
view allAdverse 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.