FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K Number: K152582
·
Decision Dec 3, 2015
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
55
Review Days
84
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Basic Information
- Device Name
- CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
- K Number
- K152582
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Volcano Corporation
- Date Received
- September 10, 2015
- Decision Date
- December 3, 2015
- 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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