DeviceClearance

Eclipse PRO— 510(k) K211651

Substantially Equivalent

Spacelabs Healthcare, Ltd.

FDA 510(k) clearance K211651 for Eclipse PRO, Substantially Equivalent on 2021-11-22. Applicant: Spacelabs Healthcare, Ltd.. Device class: 2.

Clearance details

Applicant
Spacelabs Healthcare, Ltd.
Product code
Code MWJ
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hertford, GB
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K211651

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211651.

Data sourced from openFDA. This site is unofficial and independent of the FDA.