FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K Number: K131765
·
Decision Dec 20, 2013
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
82
Review Days
186
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Basic Information
- Device Name
- ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
- K Number
- K131765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmed Corporation
- Date Received
- June 17, 2013
- Decision Date
- December 20, 2013
- 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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