Cleared Traditional

NEO NEST

K112547 · Denovo Proucts, LLC · Physical Medicine

Mar 2012

Decision

187d

Days

Class 1

Risk

About This 510(k) Submission

K112547 is an FDA 510(k) clearance for the NEO NEST, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Denovo Proucts, LLC (Ft. Myers, US). The FDA issued a Cleared decision on March 6, 2012, 187 days after receiving the submission on September 1, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number	K112547 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2011
Decision Date	March 06, 2012
Days to Decision	187 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement