FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K Number: K041178
·
Decision Jul 16, 2004
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
63
Applicant Total
56
Review Days
72
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Basic Information
- Device Name
- EMPOWER TRANSFER SET, (CAT. NO. 7725)
- K Number
- K041178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- E-Z-Em, Inc.
- Date Received
- May 5, 2004
- Decision Date
- July 16, 2004
- Product Code
- FPK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPK | Tubing, Fluid Delivery | FDA class 2 | General Hospital |
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Other Clearances by E-Z-Em, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | Jun 13, 2007 | Substantially Equivalent |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | Apr 13, 2007 | Substantially Equivalent |
| K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 | Nov 2, 2006 | Substantially Equivalent |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | Dec 27, 2005 | Substantially Equivalent |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | Jun 19, 2003 | Substantially Equivalent |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | Apr 16, 2003 | Substantially Equivalent |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | Feb 19, 2002 | Substantially Equivalent |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | May 16, 2001 | Substantially Equivalent |
| K974621 | PERCUPUMP II WITH EDA | Jan 27, 1998 | Substantially Equivalent |
| K961845 | PERCUPUMP II WITH EDA | Jan 23, 1997 | Substantially Equivalent |