Cleared Traditional

VITALOGRAPH 2110 SOFTWARE INTERFACE

K950854 · Vitalograph , Ltd. · Cardiovascular

Oct 1995

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K950854 is an FDA 510(k) clearance for the VITALOGRAPH 2110 SOFTWARE INTERFACE, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on October 12, 1995, 227 days after receiving the submission on February 27, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K950854 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 1995
Decision Date	October 12, 1995
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF