Cleared Traditional

K961845 - PERCUPUMP II WITH EDA
(FDA 510(k) Clearance)

K961845 · E-Z-Em, Inc. · Radiology device

Jan 1997

Decision

255d

Days

Class 2

Risk

K961845 is an FDA 510(k) clearance for the PERCUPUMP II WITH EDA. This device is classified as 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 23, 1997, 255 days after receiving the submission on May 13, 1996.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number	K961845 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 13, 1996
Decision Date	January 23, 1997
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement