The following data is part of a premarket notification filed by Meridian Medical Technologies, Inc. with the FDA for Cardiobeeper Cb-12l.
| Device ID | K965101 |
| 510k Number | K965101 |
| Device Name: | CARDIOBEEPER CB-12L |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MERIDIAN MEDICAL TECHNOLOGIES, INC. 49 PLAIN ST. N. Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer MERIDIAN MEDICAL TECHNOLOGIES, INC. 49 PLAIN ST. N. Attleboro, MA 02760 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-20 |
| Decision Date | 1997-03-17 |
| Summary: | summary |