HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)— 510(k) K050410

Name: FDA 510(k) clearance K050410
Creator: U.S. Food and Drug Administration
Published: 2005-07-14

Substantially Equivalent

Hwang Sun Enterprise Co., Ltd.

FDA 510(k) clearance K050410 for HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ), Substantially Equivalent on 2005-07-14. Applicant: Hwang Sun Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hwang Sun Enterprise Co., Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2005-02-17
Decision date: 2005-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middle Island, NY, US

Download summary PDF View on FDA.gov ↗

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