The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Nasal Co2 Sampling/o2 Delivery Cannula.
| Device ID | K063813 |
| 510k Number | K063813 |
| Device Name: | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2008-03-26 |