The following data is part of a premarket notification filed by C.e. Diagnosis, Inc. with the FDA for C.e. Vascular Machine.
| Device ID | K960840 |
| 510k Number | K960840 |
| Device Name: | C.E. VASCULAR MACHINE |
| Classification | Plethysmograph, Volume |
| Applicant | C.E. DIAGNOSIS, INC. ONE MULBERRY ST. EAST ELLIJAY, GA 30539 |
| Contact | CARLOS A SELMONOSKY |
| Correspondent | CARLOS A SELMONOSKY C.E. DIAGNOSIS, INC. ONE MULBERRY ST. EAST ELLIJAY, GA 30539 |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-29 |
| Decision Date | 1997-03-28 |