The following data is part of a premarket notification filed by Design Technologies, Inc. with the FDA for Neb-u-vent.
| Device ID | K872038 |
| 510k Number | K872038 |
| Device Name: | NEB-U-VENT |
| Classification | Flowmeter, Nonback-pressure Compensated, Bourdon Gauge |
| Applicant | DESIGN TECHNOLOGIES, INC. 1471 PINEWOOD ST. Rahway, NJ 07065 |
| Contact | Louis G Acri |
| Correspondent | Louis G Acri DESIGN TECHNOLOGIES, INC. 1471 PINEWOOD ST. Rahway, NJ 07065 |
| Product Code | CCN |
| CFR Regulation Number | 868.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-27 |
| Decision Date | 1987-08-10 |