Cleared Traditional

PERCUPUMP II WITH EDA

K974621 · E-Z-Em, Inc. · Radiology
Jan 1998
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K974621 is an FDA 510(k) clearance for the PERCUPUMP II WITH EDA, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on January 27, 1998, 47 days after receiving the submission on December 11, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K974621 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1997
Decision Date January 27, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770