The following data is part of a premarket notification filed by Hamilton Medical, Inc. with the FDA for Leonardo Information System.
| Device ID | K894426 |
| 510k Number | K894426 |
| Device Name: | LEONARDO INFORMATION SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno, NV 89520 |
| Contact | Tim Cowart |
| Correspondent | Tim Cowart HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno, NV 89520 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-26 |