Cleared Traditional

K913038 - SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (FDA 510(k) Clearance)

K913038 · Spacelabs, Inc. · Cardiovascular device

Oct 1991

Decision

87d

Days

Class 2

Risk

K913038 is an FDA 510(k) clearance for the SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION. This device is classified as 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 October 4, 1991, 87 days after receiving the submission on July 9, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K913038 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 09, 1991
Decision Date	October 04, 1991
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement