Cleared Traditional

Spacelabs Lifescreen PRO Analyzer

K201921 · Spacelabs Healthcare, Ltd. · Cardiovascular
Mar 2021
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K201921 is an FDA 510(k) clearance for the Spacelabs Lifescreen PRO Analyzer, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Spacelabs Healthcare, Ltd. (Hertford, GB). The FDA issued a Cleared decision on March 26, 2021, 259 days after receiving the submission on July 10, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K201921 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2020
Decision Date March 26, 2021
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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