The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Heartcard Cardiac Event Monitor.
| Device ID | K944362 |
| 510k Number | K944362 |
| Device Name: | HEARTCARD CARDIAC EVENT MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1995-09-07 |