HEALTH MANAGER, VERSION 1.1— 510(k) K081499
Substantially EquivalentBiocomfort Diagnostics GmbH & Co. KG
FDA 510(k) clearance K081499 for HEALTH MANAGER, VERSION 1.1, Substantially Equivalent on 2009-01-16. Applicant: Biocomfort Diagnostics GmbH & Co. KG.
Clearance details
- Applicant
- Biocomfort Diagnostics GmbH & Co. KG
- Product code
- Code DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Neuhausen A.D.F., DE
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.