The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Breas Ha50 Humidifier, Model Ha50.
| Device ID | K002454 |
| 510k Number | K002454 |
| Device Name: | BREAS HA50 HUMIDIFIER, MODEL HA50 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood, CO |
| Contact | Thomas W Dielmann |
| Correspondent | Thomas W Dielmann VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood, CO |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-10 |
| Decision Date | 2001-03-07 |