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
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K813298conpharCONPHAR DELEE HILLIS STETHOSCOPEDecember 8, 1981
K761338j. sklar mfg. coLEFF STETHOSCOPE FOR FETAL HEARTJanuary 12, 1977