510(k) K970197 ยท ILO Pack, Hot Or Cold, Water Circulating
HTP-1500 LOCALIZED HEAT THERAPY PUMP
| Applicant | Adroit Medical Systems, Inc., Loudon TN, US |
| Decision | Substantially Equivalent, Sep 10, 1997 |
| Received | Jan 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970197
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.