FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PERICAM PSI
K Number: K120884
·
Decision Jul 3, 2012
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
4
Review Days
102
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Basic Information
- Device Name
- PERICAM PSI
- K Number
- K120884
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perimed AB
- Date Received
- March 23, 2012
- Decision Date
- July 3, 2012
- Product Code
- DPT
- 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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