The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Pressurechek Disosable Column Manometer.
| Device ID | K120118 |
| 510k Number | K120118 |
| Device Name: | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| 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 | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-05-24 |