Product Code: EXZ FDA class 1 21 CFR 876.1500

Equipment, Photographic, For Physiologic Function Monitor

Gastroenterology, Urology

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.

510(k)s
0
FEI Numbers
3
Registration Numbers
3
Unique Applicants
0
Years Active

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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

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

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.