510(k) K940160 ยท ILO Pack, Hot Or Cold, Water Circulating
TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
| Applicant | Burke Neutech, Inc., Largo FL, US |
| Decision | Substantially Equivalent, May 27, 1994 |
| Received | Jan 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940160
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.