510(k) K191166 ยท PMC Scalp Cooling System
DigniCap Delta
| Applicant | Dignitana, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jun 26, 2019 |
| Received | May 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191166
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.