K960840 is an FDA 510(k) clearance for the C.E. VASCULAR MACHINE. This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by C.E. Diagnosis, Inc. (East Ellijay, US). The FDA issued a Cleared decision on March 28, 1997, 393 days after receiving the submission on February 29, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K960840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 1996 |
| Decision Date | March 28, 1997 |
| Days to Decision | 393 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | JEH — Plethysmograph, Volume |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1760 |