Equipment, Photographic, For Physiologic Function Monitor
The photographic equipment for physiologic function monitoring is a camera or imaging system used to document and record findings during gastroenterological or urological diagnostic procedures, serving as an adjunct to endoscopy or other functional assessments. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket notification requirement. The product code is EXZ, regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EXZ
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.