The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for King Of Hearts Express (e.x.) Monitor.
| Device ID | K920984 |
| 510k Number | K920984 |
| Device Name: | KING OF HEARTS EXPRESS (E.X.) MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Semler |
| Correspondent | 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 | 1992-03-02 |
| Decision Date | 1992-10-14 |