ENSITE 3000 SYSTEM, MODEL EE3000
Device Facts
| Record ID | K001437 |
|---|---|
| Device Name | ENSITE 3000 SYSTEM, MODEL EE3000 |
| Applicant | Endocardial Solutions, Inc. |
| Product Code | DQK · Cardiovascular |
| Decision Date | Jun 7, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
