The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Cardiomagic 2000 Software.
| Device ID | K964036 |
| 510k Number | K964036 |
| Device Name: | CARDIOMAGIC 2000 SOFTWARE |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INSTROMEDIX, INC. 7431 N.E. EVERGREEN PKWY., ONE TECHNOLOGY CENTER Hillsboro, OR 97124 -5898 |
| Contact | Herbert H Semler |
| Correspondent | Herbert H Semler INSTROMEDIX, INC. 7431 N.E. EVERGREEN PKWY., ONE TECHNOLOGY CENTER 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 | 1996-10-08 |
| Decision Date | 1997-07-18 |
| Summary: | summary |