PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
Device Facts
| Record ID | K001852 |
|---|---|
| Device Name | PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE |
| Applicant | Itamar Medical (C.M.) 1997 , Ltd. |
| Product Code | DQK · Cardiovascular |
| Decision Date | Feb 21, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
