The following data is part of a premarket notification filed by Cooler Heads Care, Inc. with the FDA for Portable Scalp Cooling System.
| Device ID | K211526 |
| 510k Number | K211526 |
| Device Name: | Portable Scalp Cooling System |
| Classification | Scalp Cooling System |
| Applicant | Cooler Heads Care, Inc. 2801 B Street, #209 San Diego, CA 92102 |
| Contact | Kate Dilligan |
| Correspondent | Pierre Bounaud Acknowledge Regulatory Strategies 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | PMC |
| CFR Regulation Number | 878.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2021-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851682007562 | K211526 | 000 |
| 00850051245048 | K211526 | 000 |
| 00850051245031 | K211526 | 000 |
| 00850051245017 | K211526 | 000 |
| 00850051245000 | K211526 | 000 |
| 00850051245130 | K211526 | 000 |
| 00850051245123 | K211526 | 000 |
| 00850051245116 | K211526 | 000 |
| 00850051245192 | K211526 | 000 |