Product Code: BYN FDA class 1 21 CFR 868.5365

Chair, Posture, For Cardiac And Pulmonary Treatment

Anesthesiology

The Chair, Posture, for Cardiac and Pulmonary Treatment is a specialized chair designed to position patients in optimal postures for cardiac and pulmonary therapy, facilitating respiratory mechanics and circulatory function during treatment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYN, regulated under 21 CFR 868.5365 in the Anesthesiology specialty.

510(k)s
1
FEI Numbers
5
Registration Numbers
5
Unique Applicants
1
Years Active

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Basic Information

Product Code
BYN
Device Class
FDA class 1
Regulation Number
868.5365
Medical Specialty
Anesthesiology
Review Panel
AN
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K873039 MODEL 820 TOP=TRAK

FEI Numbers

This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.