510(k) DEN150010
- Device
- Dignitana AB DigniCap System
- Applicant
- Dignitana AB
- 510(k) number
- DEN150010
- Product code
- PMC
- Decision
- Unknown (DENG)
- Decision date
- 2015-12-08
- Date received
- 2015-03-06
- Regulation
- 878.4360
- Classification name
- Scalp Cooling System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAN RICHARDSSON
- Address
- Traktorgranden 3 Lund SE se-226 60 se-226 60
FDA Registration Numbers#
- 3012187635
- 3008938259
- 3008888703
- 3044829899
- 3012146457
- 1648700
- 3021619527
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PMC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | 2025-11-25 |
| K211526 | Portable Scalp Cooling System | Cooler Heads Care, Inc. | 2021-10-21 |
| K191166 | DigniCap Delta | Dignitana, Inc. | 2019-06-26 |
| K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | 2018-06-07 |
| K170871 | DigniCap Scalp Cooling System | Dignitana AB | 2017-07-03 |
| K163484 | Paxman Scalp Cooler | Paxman Coolers Limited | 2017-04-17 |