AMEDA HAND BREAST PUMP— 510(k) K823591

Name: FDA 510(k) clearance K823591
Creator: U.S. Food and Drug Administration
Published: 1982-12-28

Substantially Equivalent

Burditt & Calkins-Siemens-Elema

FDA 510(k) clearance K823591 for AMEDA HAND BREAST PUMP, Substantially Equivalent on 1982-12-28. Applicant: Burditt & Calkins-Siemens-Elema. Device class: 1.

Clearance details

Applicant: Burditt & Calkins-Siemens-Elema
Product code: Code HGY
Device class: Class 1
Regulation: 21 CFR 884.5150
Advisory panel: Obstetrics/Gynecology
Date received: 1982-12-06
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGY

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K830344 — SIEMENS-ELMA PULSE GENERATOR #7181983-05-27
K823435 — MON-A-THERM MYOCARDIAL TEMP. SENSOR1982-12-30
K822239 — COAXIAL BIPOLAR PACING ELECTRODE1982-10-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.