The following data is part of a premarket notification filed by Meridian Medical Technologies Ltd. with the FDA for Cardiobeeper Cb12/12, Model Cb12/12.
| Device ID | K002310 |
| 510k Number | K002310 |
| Device Name: | CARDIOBEEPER CB12/12, MODEL CB12/12 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MERIDIAN MEDICAL TECHNOLOGIES LTD. 207 AIRPORT RD., WEST Belfast, IE Bt3 9ed |
| Contact | Gerard Lynn |
| Correspondent | Gerard Lynn MERIDIAN MEDICAL TECHNOLOGIES LTD. 207 AIRPORT RD., WEST Belfast, IE Bt3 9ed |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-31 |
| Decision Date | 2000-10-25 |