510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HGNClass I

Stethoscope, Fetal

21 CFR 884.2900 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGN is the FDA product code for Stethoscope, Fetal, a class I device type, regulated under 21 CFR 884.2900. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HGN
Device name
Stethoscope, Fetal
Regulation
21 CFR 884.2900
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HGN

By decision year
2 clearances under product code HGN with a decision year between 1977 and 1981, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HGN by decision year
YearClearances
19771
19811

Applicants with the most clearances

Product code HGN
Applicants holding the most 510(k) clearances under product code HGN
ApplicantClearances
Conphar, Inc.1
J. Sklar Mfg. Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order