510(k) K013201 ยท GEX Powered Laser Surgical Instrument
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
| Applicant | Cardiofocus, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Mar 18, 2002 |
| Received | Sep 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013201
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.