The following data is part of a premarket notification filed by Meridian Medical Technologies, Inc. with the FDA for Prime Ecg System.
| Device ID | K012414 |
| 510k Number | K012414 |
| Device Name: | PRIME ECG SYSTEM |
| Classification | Electrocardiograph |
| Applicant | MERIDIAN MEDICAL TECHNOLOGIES, INC. 10240 OLD COLUMBIA RD. Columbia, MD 21046 |
| Contact | Jamil F Laham |
| Correspondent | Jamil F Laham MERIDIAN MEDICAL TECHNOLOGIES, INC. 10240 OLD COLUMBIA RD. Columbia, MD 21046 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2002-03-06 |
| Summary: | summary |