510(k) K972649 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
CARDIOCALL CARDIAC EVENT RECORDER
| Applicant | Reynolds Medical , Ltd., Hasbrouck NJ, US |
| Decision | Substantially Equivalent, Dec 4, 1997 |
| Received | Jul 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2015 | Spacelabs Healthcare Inc Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00
Product Usage: The CardioCall event recorder is worn by the patient to record a short Terminated |
DXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.