The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab 6000 Series Humidifier.
| Device ID | K093617 |
| 510k Number | K093617 |
| Device Name: | VENTLAB 6000 SERIES HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | VENTLAB CORP. 155 BOYCE DRIVE Mocksville, NC 27028 |
| Contact | James A Cochie |
| Correspondent | James A Cochie VENTLAB CORP. 155 BOYCE DRIVE Mocksville, NC 27028 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2011-01-27 |