The following data is part of a premarket notification filed by Meridian Dynamics Biomedical, Inc with the FDA for Ecg Pen.
| Device ID | K103077 |
| 510k Number | K103077 |
| Device Name: | ECG PEN |
| Classification | Electrocardiograph |
| Applicant | MERIDIAN DYNAMICS BIOMEDICAL, INC 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich MERIDIAN DYNAMICS BIOMEDICAL, INC 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-18 |
| Decision Date | 2011-07-13 |
| Summary: | summary |