Chair, Posture, For Cardiac And Pulmonary Treatment
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K873039 | MODEL 820 TOP=TRAK | Feb 11, 1988 | Substantially Equivalent | Sierra Laboratories, Inc. |
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.