510(k) K061023 ยท NZE Hyperthermia Monitor
THERMOSUIT SYSTEM
| Applicant | Life Recovery Systems Hd, LLC, Durham CT, US |
| Decision | Substantially Equivalent, Sep 20, 2006 |
| Received | Apr 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Life Recovery Systems HD, LLC ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA
Tel.: (973) 283-2800
FAx.: (973) 283-2910
Temperature reduction in patients where clinically indic Terminated |
NZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.