DECITEL AUSCULSCOPE— 510(k) K860994

Name: FDA 510(k) clearance K860994
Creator: U.S. Food and Drug Administration
Published: 1986-11-07

Substantially Equivalent

Bloomfield Research and Development, Inc.

FDA 510(k) clearance K860994 for DECITEL AUSCULSCOPE, Substantially Equivalent on 1986-11-07. Applicant: Bloomfield Research and Development, Inc.. Device class: 2.

Clearance details

Applicant: Bloomfield Research and Development, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1986-03-17
Decision date: 1986-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilton Head, SC, US

Download summary PDF View on FDA.gov ↗

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