The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Eventstation Ecg Trans-telephonic Receiving System.
| Device ID | K991211 |
| 510k Number | K991211 |
| Device Name: | EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | REYNOLDS MEDICAL LTD. 1-2 HARFORDE CT., FOXHOLES BUSINESS PARK Hertford, GB Sg13 7nw |
| Contact | George Myers |
| Correspondent | George Myers REYNOLDS MEDICAL LTD. 1-2 HARFORDE CT., FOXHOLES BUSINESS PARK Hertford, GB Sg13 7nw |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-09 |
| Decision Date | 1999-07-08 |
| Summary: | summary |