SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT
Device Facts
| Record ID | K760448 |
|---|---|
| Device Name | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT |
| Applicant | Instrumentation Laboratory CO |
| Product Code | DXL · Cardiovascular |
| Decision Date | Aug 27, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1660 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.
