The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Mallard Medical Model 2400 Anesthesia Ventilator.
| Device ID | K902405 |
| 510k Number | K902405 |
| Device Name: | MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | MALLINCKRODT MEDICAL 17972 SKY PARK CIR., STE A Irvine, CA 92714 |
| Contact | Bob Pearson |
| Correspondent | Bob Pearson MALLINCKRODT MEDICAL 17972 SKY PARK CIR., STE A Irvine, CA 92714 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-31 |
| Decision Date | 1991-03-04 |