510(k) K163484
K163484 is an FDA 510(k) premarket notification submitted by Paxman Coolers Limited for the device "Paxman Scalp Cooler". The FDA issued a decision of Substantially Equivalent on April 17, 2017. The device falls under product code PMC (Scalp Cooling System), a Class II device regulated under 21 CFR 878.4360. Paxman Coolers Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2017
- Date Received
- December 12, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scalp Cooling System
- Device Class
- Class II
- Regulation Number
- 878.4360
- Review Panel
- SU
- Submission Type
A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.