The following data is part of a premarket notification filed by Macquarie Medical Systems with the FDA for Ct 200 Electrocardiograph.
| Device ID | K961798 |
| 510k Number | K961798 |
| Device Name: | CT 200 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 | 1996-05-09 |
| Decision Date | 1998-08-05 |
| Summary: | summary |