The following data is part of a premarket notification filed by Paxman Coolers Limited with the FDA for Paxman Scalp Cooler.
| Device ID | K163484 |
| 510k Number | K163484 |
| Device Name: | Paxman Scalp Cooler |
| Classification | Scalp Cooling System |
| Applicant | Paxman Coolers Limited International House, Penistone Road, Fenay Bridge Huddersfield, GB Hd8 0le |
| Contact | Richard Paxman |
| Correspondent | Richard A. Vincins Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | PMC |
| CFR Regulation Number | 878.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B561PSCSCAPSMALL0 | K163484 | 000 |
| B561CAPSIZINGPACKA1 | K163484 | 000 |
| B561COOLANTBATCH1 | K163484 | 000 |
| B561PSCSCAPMEDSML0 | K163484 | 000 |
| B561PSCSCAPASIANLARGE0 | K163484 | 000 |
| B561PSCSCAPASIANMEDIUM0 | K163484 | 000 |
| B561PSCSCAPASIANSMALL0 | K163484 | 000 |
| B5611LCOOLANT0 | K163484 | 000 |
| B5613LCOOLANT0 | K163484 | 000 |
| B561ACCESSORIES2 | K163484 | 000 |
| B561CAPSIZINGPACK1 | K163484 | 000 |
| B561COOLANTCOMMPACK1 | K163484 | 000 |
| B561PSCS1115VPFU0 | K163484 | 000 |
| B561PSCS2115VPFU0 | K163484 | 000 |
| B561PSCSCAPLARGE0 | K163484 | 000 |
| B561PSCSCAPMEDIUM0 | K163484 | 000 |
| B561CAPBATCH1 | K163484 | 000 |