MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN— 510(k) K870841

Name: FDA 510(k) clearance K870841
Creator: U.S. Food and Drug Administration
Published: 1988-02-02

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K870841 for MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN, Substantially Equivalent on 1988-02-02. Applicant: Directed Energy, Inc.. Device class: 2.

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1987-02-26
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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