Cleared Traditional

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM

K951605 · Spacelabs, Inc. · Cardiovascular

Jul 1995

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K951605 is an FDA 510(k) clearance for the SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on July 14, 1995, 98 days after receiving the submission on April 7, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K951605 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 1995
Decision Date	July 14, 1995
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement