BYT · Class II · 21 CFR 868.5935

FDA Product Code BYT: Ventilator, External Body, Negative Pressure, Adult (cuirass)

Leading manufacturers include Respironics, Inc. and Quinton, Inc..

21
Total
21
Cleared
97d
Avg days
1979
Since

FDA 510(k) Cleared Ventilator, External Body, Negative Pressure, Adult (cuirass) Devices (Product Code BYT)

21 devices
1–21 of 21
Cleared Jul 21, 1993
HAYEK OSCILLATOR(TM)
K924341
Respironics, Inc.
Anesthesiology · 328d
Cleared Dec 22, 1989
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849
Respironics, Inc.
Anesthesiology · 80d
Cleared Nov 13, 1986
Q101 DIAGNOSTIC SPIROMETER
K863300
Quinton, Inc.
Anesthesiology · 80d

About Product Code BYT - Regulatory Context