INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER— 510(k) K082512
Substantially EquivalentDimensional Dosing Systems, Inc.
FDA 510(k) clearance K082512 for INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER, Substantially Equivalent on 2008-11-07. Applicant: Dimensional Dosing Systems, Inc..
Clearance details
- Applicant
- Dimensional Dosing Systems, Inc.
- Product code
- Code NDC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
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.