The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Ppg Biomedical Ventilator Model Irisa.
| Device ID | K896442 |
| 510k Number | K896442 |
| Device Name: | PPG BIOMEDICAL VENTILATOR MODEL IRISA |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | John J Talarico |
| Correspondent | John J Talarico 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 | 1989-11-09 |
| Decision Date | 1990-04-16 |