The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for King Of Hearts Scepter.
| Device ID | K923221 |
| 510k Number | K923221 |
| Device Name: | KING OF HEARTS SCEPTER |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1993-03-08 |