The following data is part of a premarket notification filed by Janssen Pharmaceutica, Inc. with the FDA for Odac-on Demand Aralgesia By Computer-infusion Pump.
| Device ID | K850792 |
| 510k Number | K850792 |
| Device Name: | ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | JANSSEN PHARMACEUTICA, INC. 40 KINGSBRIDGE RD. Piscataway, NJ 08854 |
| Contact | Donald P Cox |
| Correspondent | Donald P Cox JANSSEN PHARMACEUTICA, INC. 40 KINGSBRIDGE RD. Piscataway, NJ 08854 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-11-13 |