← FDA Medical Device Classifications

Set, Tubing And Support, Ventilator (W Harness)

BZO · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5975

Classification

FDA Product Code
BZO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 868.5975
Review panel
AN
Medical specialty
Anesthesiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
88
Registered establishments
147

Source

Authoritative
FDA Device Classification database
Machine
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