The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Exhalation Manifold Vx-2000 A & Vx-2000 B.
| Device ID | K900115 |
| 510k Number | K900115 |
| Device Name: | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
| Contact | Gregory Lau |
| Correspondent | Gregory Lau VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-09 |
| Decision Date | 1990-02-22 |