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.. Device class: 2.
Clearance details
- Applicant
- Churchill Medical Systems, Inc.
- Product code
- Code KPE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Dover, NH, US
Recent devices under product code KPE
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- K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
- K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- K013950 — VENTED VIAL ACCESS DEVICE
- K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK
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.