HGN — Stethoscope, Fetal Class I

FDA Device Classification

FDA product code HGN covers "Stethoscope, Fetal", a Class I medical device regulated under 21 CFR 884.2900. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
HGN
Device Class
Class I
Regulation Number
884.2900
Submission Type
510(k) Exempt
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K813298ConpharCONPHAR DELEE HILLIS STETHOSCOPEDec 8, 1981
K761338J. Sklar Mfg. CoLEFF STETHOSCOPE FOR FETAL HEARTJan 12, 1977

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.