The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Nmc Cycler Machine.
| Device ID | K905809 |
| 510k Number | K905809 |
| Device Name: | NMC CYCLER MACHINE |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | William R Matthews |
| Correspondent | William R Matthews NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1992-02-25 |