FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
DigniCap Scalp Cooling System
K Number: K170871
·
Decision Jul 3, 2017
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
2
Review Days
102
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Basic Information
- Device Name
- DigniCap Scalp Cooling System
- K Number
- K170871
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4360
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dignitana AB
- Date Received
- March 23, 2017
- Decision Date
- July 3, 2017
- Product Code
- PMC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| PMC | Scalp Cooling System | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PMC), ordered by most recent decision date.
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Paxman Scalp Cooler
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Dignitana AB DigniCap System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Dignitana AB
| K Number | Device Name | ||
|---|---|---|---|
| DEN150010 | Dignitana AB DigniCap System | Dec 8, 2015 | Unknown |