FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
NOA III ENTERAL NUTRITION PUMP
K Number: K040957
·
Decision May 21, 2004
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
9
Review Days
38
Basic Information
- Device Name
- NOA III ENTERAL NUTRITION PUMP
- K Number
- K040957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CAESAREA MEDICAL ELECTRONICS LTD.
- Date Received
- April 13, 2004
- Decision Date
- May 21, 2004
- Product Code
- LZH
- 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 |
|---|---|---|---|
| LZH | Pump, Infusion, Enteral | FDA class 2 | General Hospital |
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Other Clearances by CAESAREA MEDICAL ELECTRONICS LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K080954 | T34L SYRINGE DRIVER | May 16, 2008 | Substantially Equivalent |
| K070235 | BODYGUARD PAIN MANAGER INFUSION SYSTEM | May 18, 2007 | Substantially Equivalent |
| K070718 | MODIFICATION TO: BODYGUARD INFUSION SYSTEM | Apr 13, 2007 | Substantially Equivalent |
| K061325 | BODYGAURD PAIN MANAGER INFUSION SYSTEM | Aug 24, 2006 | Substantially Equivalent |
| K060479 | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM | May 12, 2006 | Substantially Equivalent |
| K050800 | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS | Nov 23, 2005 | Substantially Equivalent |
| K042696 | BODYGUARD INFUSION PUMP SYSTEM | Mar 11, 2005 | Substantially Equivalent |
| K031749 | BODYGUARD INFUSION SYSTEM | Aug 21, 2003 | Substantially Equivalent |