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 |