The following data is part of a premarket notification filed by Sigma Intl. General Medical Apparatus, Inc. with the FDA for Sigma 8000 And Sigma 8002.
| Device ID | K950766 |
| 510k Number | K950766 |
| Device Name: | SIGMA 8000 AND SIGMA 8002 |
| Classification | Pump, Infusion |
| Applicant | SIGMA INTL. GENERAL MEDICAL APPARATUS, INC. 11020 WEST CENTER ST. EXT. Medina, NY 14103 -0756 |
| Contact | Charles L Martina |
| Correspondent | Charles L Martina SIGMA INTL. GENERAL MEDICAL APPARATUS, INC. 11020 WEST CENTER ST. EXT. Medina, NY 14103 -0756 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-03-22 |