Cleared Traditional

Eclipse MINI Model 98900

K212317 · Spacelabs Healthcare, Ltd. · Cardiovascular
Nov 2022
Decision
469d
Days
Class 2
Risk

About This 510(k) Submission

K212317 is an FDA 510(k) clearance for the Eclipse MINI Model 98900, 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 7, 2022, 469 days after receiving the submission on July 26, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K212317 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2021
Decision Date November 07, 2022
Days to Decision 469 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