Cleared Traditional

POCKETCPR

K071321 · Bio-Detek, Inc. · Cardiovascular
Sep 2007
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K071321 is an FDA 510(k) clearance for the POCKETCPR, a Aid, Cardiopulmonary Resuscitation (Class II — Special Controls, product code LIX), submitted by Bio-Detek, Inc. (Pawtucket, US). The FDA issued a Cleared decision on September 12, 2007, 125 days after receiving the submission on May 10, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number K071321 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2007
Decision Date September 12, 2007
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIX — Aid, Cardiopulmonary Resuscitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5210
Definition Cpr Aid Device With Feedback (visual, Audio Or Both) On One Or More Cpr Parameters (e.g., Rate, Depth, Ventilation Ratio, Etc.), And Contains Software. Provides Real-time Feedback On Cpr Performance. Feedback Can Be Audio, Visual Or Both. Device Contains Software