CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2— 510(k) K842754

Name: FDA 510(k) clearance K842754
Creator: U.S. Food and Drug Administration
Published: 1984-11-28

Substantially Equivalent

Custom Ultrasonics

FDA 510(k) clearance K842754 for CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2, Substantially Equivalent on 1984-11-28. Applicant: Custom Ultrasonics. Device class: 1.

Clearance details

Applicant: Custom Ultrasonics
Product code: Code FLG
Device class: Class 1
Regulation: 21 CFR 880.6150
Advisory panel: General Hospital
Date received: 1984-07-16
Decision date: 1984-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buckingham, PA, US

Download summary PDF View on FDA.gov ↗

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