BOLUS COMPENSATOR— 510(k) K091911

Substantially Equivalent

.Decimal, Inc.

FDA 510(k) clearance K091911 for BOLUS COMPENSATOR, Substantially Equivalent on 2009-07-21. 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: 2009-06-25
Decision date: 2009-07-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Sanford, FL, 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.