.DECIMAL PROTON APERTURE— 510(k) K132236

Substantially Equivalent

.Decimal, Inc.

FDA 510(k) clearance K132236 for .DECIMAL PROTON APERTURE, Substantially Equivalent on 2013-10-16. Applicant: .Decimal, Inc.. Device class: 2.

Clearance details

Applicant: .Decimal, Inc.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2013-07-18
Decision date: 2013-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanford, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from .Decimal, Inc.

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K083672 — P.D SOFTWARE2009-04-13

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