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 |