510(k) K003759 ยท GWM Device, Monitoring, Intracranial Pressure
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
| Applicant | Aesculap, Inc., Pleasant Hill CA, US |
| Decision | Substantially Equivalent, Jun 28, 2001 |
| Received | Dec 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2009 | Spiegelberg Gmbh & Co. KG Spiegelberg Brain Pressure Monitoring System
Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P
Product Usage: lntracranial pressure measuring probes are used to measure intracr Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.