The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Cardio Iv/gxt Stress Testing System.
| Device ID | K844744 |
| 510k Number | K844744 |
| Device Name: | CARDIO IV/GXT STRESS TESTING SYSTEM |
| Classification | Electrocardiograph |
| Applicant | INTL. MEDICAL, INC. 64 INVERNESS DR EAST Englewood, CO 80110 |
| Contact | Robert C Hale |
| Correspondent | Robert C Hale INTL. MEDICAL, INC. 64 INVERNESS DR EAST Englewood, CO 80110 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-05 |
| Decision Date | 1985-01-23 |