510(k) K231063 · BTA Pump, Portable, Aspiration (Manual Or Powered)
SOMAVAC® 100 Sustained Vacuum System
| Applicant | Somavac Medical Solutions, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, May 12, 2023 |
| Received | Apr 14, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231063
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.