SOLID GEL PAD— 510(k) K131905

Substantially Equivalent

Bluemtech

FDA 510(k) clearance K131905 for SOLID GEL PAD, Substantially Equivalent on 2013-07-18. Applicant: Bluemtech. Device class: 2.

Clearance details

Applicant: Bluemtech
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2013-06-26
Decision date: 2013-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.