BMT ANSCORE HEALTH MANAGEMENT SYSTEM— 510(k) K993875
Substantially EquivalentBoston Medical Technologies, Inc.
FDA 510(k) clearance K993875 for BMT ANSCORE HEALTH MANAGEMENT SYSTEM, Substantially Equivalent on 2000-08-11. Applicant: Boston Medical Technologies, Inc..
Clearance details
- Applicant
- Boston Medical Technologies, Inc.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wakefield, MA, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.