Panels › General, Plastic Surgery › Product code PMC · Class 2
Scalp Cooling System
Regulation 878.4360
1510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PMC
| Company | 510(k)s | Recalls |
|---|---|---|
| Dignitana AB | 3 | 1 |
| Paxman Coolers Limited | 2 | 0 |
| Cooler Heads Care, Inc. | 1 | 0 |
| Stemtech Medical Devices Private Limited | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2021 | Dignitana, Inc. DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling:
The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN),
DigniCap Delta Scalp Cooling Wrap (LA Terminated |
PMC | K191166 |
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