The following data is part of a premarket notification filed by Healthwatch, Inc. with the FDA for Cambridge Pc/gxt Stress Test System.
| Device ID | K921331 |
| 510k Number | K921331 |
| Device Name: | CAMBRIDGE PC/GXT STRESS TEST SYSTEM |
| Classification | Electrocardiograph |
| Applicant | HEALTHWATCH, INC. 3400 INDUSTRIAL LN. SUITE A Broomfield, CO 80020 |
| Contact | Jim Stephens |
| Correspondent | Jim Stephens HEALTHWATCH, INC. 3400 INDUSTRIAL LN. SUITE A Broomfield, CO 80020 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-05-11 |