510(k) K083271 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
| Applicant | Nihon Kohden America, Inc., Foothill CA, US |
| Decision | Substantially Equivalent, Dec 24, 2008 |
| Received | Nov 6, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083271
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.