510(k) K940858 ยท ILO Pack, Hot Or Cold, Water Circulating
THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
| Applicant | Innovation Sports, Inc., Irvine CA, US |
| Decision | Substantially Equivalent for Some Indications, Jul 12, 1994 |
| Received | Feb 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940858
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.