510(k) K023418 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
HEARTONE EVENT RECORDER AND TRANSMITTER
| Applicant | Aerotel Medical Systems (1998) , Ltd., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Nov 6, 2002 |
| Received | Oct 11, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023418
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.