FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
K Number: K001762
·
Decision Jun 13, 2000
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
174
Applicant Total
3
Review Days
4
Basic Information
- Device Name
- PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
- K Number
- K001762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PULSION MEDICAL SYSTEMS, INC.
- Date Received
- June 9, 2000
- Decision Date
- June 13, 2000
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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