Device, Rebreathing
The Device, Rebreathing is a device used in respiratory therapy or anesthesia that allows a patient to partially or fully rebreathe their exhaled gases, typically to manage carbon dioxide levels or conserve anesthetic agents. 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 BYW, regulated under 21 CFR 868.5675 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BYW
- Device Class
- FDA class 1
- Regulation Number
- 868.5675
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.