ENDOMYOCARDIAL BIOPSY DEVICE— 510(k) K870186

Name: FDA 510(k) clearance K870186
Creator: U.S. Food and Drug Administration
Published: 1987-02-20

Substantially Equivalent

Mansfield Scientific, Inc.

FDA 510(k) clearance K870186 for ENDOMYOCARDIAL BIOPSY DEVICE, Substantially Equivalent on 1987-02-20. Applicant: Mansfield Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Mansfield Scientific, Inc.
Product code: Code DWZ
Device class: Class 2
Regulation: 21 CFR 870.4075
Advisory panel: Cardiovascular
Date received: 1987-01-16
Decision date: 1987-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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