CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER— 510(k) K041038
Substantially EquivalentChurchill Medical Systems, Inc.
FDA 510(k) clearance K041038 for CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER, Substantially Equivalent on 2004-12-21. Applicant: Churchill Medical Systems, Inc..
Clearance details
- Applicant
- Churchill Medical Systems, Inc.
- Product code
- Code KPE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Dover, NH, US
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.