The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Honeywell Electronic Ventilator Ev-a.
| Device ID | K853501 |
| 510k Number | K853501 |
| Device Name: | HONEYWELL ELECTRONIC VENTILATOR EV-A |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | Martin Kutik |
| Correspondent | Martin Kutik HONEYWELL, 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 | 1985-08-20 |
| Decision Date | 1986-04-04 |