Chair, Blood Donor
The Blood Donor Chair is a specially designed reclining chair used in blood donation settings to safely and comfortably position donors during the phlebotomy procedure. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FML, regulated under 21 CFR 880.6140 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FML
- Device Class
- FDA class 1
- Regulation Number
- 880.6140
- Medical Specialty
- General Hospital
- Review Panel
- HO
- 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 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.