MODEL 2200 THORACIC SUCTION PUMP— 510(k) K941525
Substantially EquivalentProduct & Educational Services
FDA 510(k) clearance K941525 for MODEL 2200 THORACIC SUCTION PUMP, Substantially Equivalent on 1994-05-18. Applicant: Product & Educational Services.
Clearance details
- Applicant
- Product & Educational Services
- Product code
- Code JCX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dolestown, PA, US
Adverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
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.