Cleared Traditional

SIMPLEABI

K110628 · Newman Medical · Radiology
May 2011
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K110628 is an FDA 510(k) clearance for the SIMPLEABI, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Newman Medical (Arvada, US). The FDA issued a Cleared decision on May 12, 2011, 70 days after receiving the submission on March 3, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K110628 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2011
Decision Date May 12, 2011
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540