The following data is part of a premarket notification filed by Hamilton Medical, Inc. with the FDA for Galileo Gold.
| Device ID | K040574 |
| 510k Number | K040574 |
| Device Name: | GALILEO GOLD |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno, NV 89520 |
| Contact | J. David Thompson |
| Correspondent | J. David Thompson 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 | 2004-03-04 |
| Decision Date | 2004-10-27 |
| Summary: | summary |