Cleared Traditional

Eclipse PRO

K211651 · Spacelabs Healthcare, Ltd. · Cardiovascular
Nov 2021
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K211651 is an FDA 510(k) clearance for the Eclipse PRO, a Electrocardiograph, Ambulatory (without Analysis) (Class II — Special Controls, product code MWJ), submitted by Spacelabs Healthcare, Ltd. (Hertford, GB). The FDA issued a Cleared decision on November 22, 2021, 178 days after receiving the submission on May 28, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K211651 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2021
Decision Date November 22, 2021
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MWJ — Electrocardiograph, Ambulatory (without Analysis)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800