The following data is part of a premarket notification filed by Electro Medical Equipment Co., Inc. with the FDA for Eme Mp3000 Monitoring And Diagnostic Resting Ecg.
| Device ID | K920867 |
| 510k Number | K920867 |
| Device Name: | EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG |
| Classification | Electrode, Electrocardiograph |
| Applicant | ELECTRO MEDICAL EQUIPMENT CO., INC. 2266 RIVERSIDE N. P.O. BOX 1806 Baton Rouge, LA 70821 |
| Contact | Leonard Carmouche |
| Correspondent | Leonard Carmouche ELECTRO MEDICAL EQUIPMENT CO., INC. 2266 RIVERSIDE N. P.O. BOX 1806 Baton Rouge, LA 70821 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1992-04-10 |