FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K Number: K021174
·
Decision Apr 29, 2003
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
3
Review Days
382
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Basic Information
- Device Name
- ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
- K Number
- K021174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Imagyn Surgical
- Date Received
- April 12, 2002
- Decision Date
- April 29, 2003
- Product Code
- DSB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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