Cleared Traditional

K063490 - SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
(FDA 510(k) Clearance)

K063490 · Spacelabs Medical, Inc. · Cardiovascular

Mar 2007

Decision

118d

Days

Class 2

Risk

K063490 is an FDA 510(k) clearance for the SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on March 15, 2007, 118 days after receiving the submission on November 17, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number	K063490 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2006
Decision Date	March 15, 2007
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF