The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Vent-mask, Cat# Vr 0010/20/30.
| Device ID | K903881 |
| 510k Number | K903881 |
| Device Name: | VENTLAB VENT-MASK, CAT# VR 0010/20/30 |
| Classification | Mask, Gas, Anesthetic |
| 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 | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-22 |
| Decision Date | 1990-09-04 |