The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for King Of Hearts Express Ii & King Of Hearts Express Ez Ii.
| Device ID | K983626 |
| 510k Number | K983626 |
| Device Name: | KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 7431 N.W. EVERGREEN PKWY. ONE TECHNOLOGY CENTER Hillsboro, OR 97124 -5898 |
| Contact | Gary N Mills |
| Correspondent | Gary N Mills ALARIS MEDICAL SYSTEMS, INC. 7431 N.W. EVERGREEN PKWY. ONE TECHNOLOGY CENTER Hillsboro, OR 97124 -5898 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1999-02-05 |
| Summary: | summary |