LEFF STETHOSCOPE FOR FETAL HEART— 510(k) K761338

Name: FDA 510(k) clearance K761338
Creator: U.S. Food and Drug Administration
Published: 1977-01-12

Substantially Equivalent

J. Sklar Mfg. Co., Inc.

FDA 510(k) clearance K761338 for LEFF STETHOSCOPE FOR FETAL HEART, Substantially Equivalent on 1977-01-12. Applicant: J. Sklar Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: J. Sklar Mfg. Co., Inc.
Product code: Code HGN
Device class: Class 1
Regulation: 21 CFR 884.2900
Advisory panel: Obstetrics/Gynecology
Date received: 1976-12-27
Decision date: 1977-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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