FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Paxman Scalp Cooler
K Number: K163484
·
Decision Apr 17, 2017
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
2
Review Days
126
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Basic Information
- Device Name
- Paxman Scalp Cooler
- K Number
- K163484
- 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
- Paxman Coolers Limited
- Date Received
- December 12, 2016
- Decision Date
- April 17, 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 |
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Other Clearances by Paxman Coolers Limited
| K Number | Device Name | ||
|---|---|---|---|
| K173032 | Paxman Scalp Cooler | Jun 7, 2018 | Substantially Equivalent |