Stethoscope, Fetal
The Fetal Stethoscope is a simple acoustic instrument, typically a Pinard horn or similar device, used to listen to fetal heart sounds through the maternal abdomen without electronic amplification, as a basic tool for fetal wellbeing assessment. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HGN, regulated under 21 CFR 884.2900, within the Obstetrics/Gynecology specialty. No special risk flags apply.
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Basic Information
- Product Code
- HGN
- Device Class
- FDA class 1
- Regulation Number
- 884.2900
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- 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 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.