FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PERIFLUX 6000
K Number: K131253
·
Decision Oct 22, 2013
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
16
Applicant Total
4
Review Days
173
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Basic Information
- Device Name
- PERIFLUX 6000
- K Number
- K131253
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.2480
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perimed AB
- Date Received
- May 2, 2013
- Decision Date
- October 22, 2013
- Product Code
- LKD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| LKD | Monitor, Carbon-Dioxide, Cutaneous | FDA class 2 | Anesthesiology |
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