The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn..
| Device ID | K090840 |
| 510k Number | K090840 |
| Device Name: | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. |
| Classification | Nebulizer (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 | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-27 |
| Decision Date | 2009-06-25 |