510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BYTClass II

Ventilator, External Body, Negative Pressure, Adult (Cuirass)

21 CFR 868.5935 / Anesthesiology
FDA source (opens on fda.gov)

BYT is the FDA product code for Ventilator, External Body, Negative Pressure, Adult (Cuirass), a class II device type, regulated under 21 CFR 868.5935. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BYT
Device name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Regulation
21 CFR 868.5935
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
0

Clearances, product code BYT

By decision year
21 clearances under product code BYT with a decision year between 1979 and 2008, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BYT by decision year
YearClearances
19791
19801
19811
19831
19842
19862
19882
19893
19903
19912
19931
20082

Applicants with the most clearances

Product code BYT
Applicants holding the most 510(k) clearances under product code BYT
ApplicantClearances
J. H. Emerson Co.3
Lifecare Services, Inc.3
Progressive Productions, Ltd.2
Respironics, Inc.2
Bear Medical Systems, Inc.1
Dima Italia SRL1
Edwards Ventilator Co.1
Emerson Intl. Co.1
Flexco Medical Instruments1
L.T.D. 3 Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code