The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Ppg Biomedical Ventilator Model Av 400.
| Device ID | K871433 |
| 510k Number | K871433 |
| Device Name: | PPG BIOMEDICAL VENTILATOR MODEL AV 400 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | Steve Brody |
| Correspondent | Steve Brody PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-05-29 |