BIOLUCENT APPLICATOR, MODEL RTA-XX— 510(k) K061241

Name: FDA 510(k) clearance K061241
Creator: U.S. Food and Drug Administration
Published: 2006-07-28

Substantially Equivalent

Biolucent, Inc.

FDA 510(k) clearance K061241 for BIOLUCENT APPLICATOR, MODEL RTA-XX, Substantially Equivalent on 2006-07-28. Applicant: Biolucent, Inc.. Device class: 2.

Clearance details

Applicant: Biolucent, Inc.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2006-05-03
Decision date: 2006-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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