Product code PMC
- Device name
- Scalp Cooling System
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4360
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset