PRODIGY NPWT SYSTEM MODEL PRODIGY 800V— 510(k) K082415
Substantially EquivalentPremco Medical Systems, Inc.
FDA 510(k) clearance K082415 for PRODIGY NPWT SYSTEM MODEL PRODIGY 800V, Substantially Equivalent on 2008-11-25. Applicant: Premco Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Premco Medical Systems, Inc.
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Rochelle, NY, US
Recent devices under product code OMP
view allAdverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.