The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for King Of Hearts 1200 Monitor.
| Device ID | K896039 |
| 510k Number | K896039 |
| Device Name: | KING OF HEARTS 1200 MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Semler, M.d. |
| Correspondent | Semler, M.d. 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 | 1989-10-16 |
| Decision Date | 1990-02-28 |