The following data is part of a premarket notification filed by Hamilton Medical, Inc. with the FDA for Veolar Ventilator.
Device ID | K901448 |
510k Number | K901448 |
Device Name: | VEOLAR VENTILATOR |
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 | 1990-03-28 |
Decision Date | 1991-12-20 |