FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K Number: K080670
·
Decision Apr 23, 2008
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
- K Number
- K080670
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atcor Medical
- Date Received
- March 10, 2008
- Decision Date
- April 23, 2008
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
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