The following data is part of a premarket notification filed by Hamilton Medical, Inc. with the FDA for Continuous Ventilator.
| Device ID | K844809 |
| 510k Number | K844809 |
| Device Name: | CONTINUOUS VENTILATOR |
| Classification | Catheter, Irrigation |
| Applicant | HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno, NV 89520 |
| Contact | Gjerde, Mba |
| Correspondent | Gjerde, Mba HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno, NV 89520 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-27 |
| Decision Date | 1985-06-27 |