MODIFICATION TO HEALTH BUDDY APPLIANCE— 510(k) K063612
Substantially EquivalentHealth Hero Network, Inc.
FDA 510(k) clearance K063612 for MODIFICATION TO HEALTH BUDDY APPLIANCE, Substantially Equivalent on 2006-12-29. Applicant: Health Hero Network, Inc.. Device class: 2.
Clearance details
- Applicant
- Health Hero Network, Inc.
- 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
- Special
- Location
- Redwood City, CA, US
Recent devices under product code DRG
view allMore clearances from Health Hero Network, Inc.
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.