The following data is part of a premarket notification filed by Macquarie Medical Systems with the FDA for Ct 100 Electrocardiograph.
| Device ID | K981951 |
| 510k Number | K981951 |
| Device Name: | CT 100 ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | MACQUARIE MEDICAL SYSTEMS 3407 BAY AVE. Chico, CA 95973 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson MACQUARIE MEDICAL SYSTEMS 3407 BAY AVE. Chico, CA 95973 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-29 |
| Decision Date | 1998-07-28 |
| Summary: | summary |