Eclipse MINI Model 98900— 510(k) K212317

Substantially Equivalent

Spacelabs Healthcare, Ltd.

FDA 510(k) clearance K212317 for Eclipse MINI Model 98900, Substantially Equivalent on 2022-11-07. Applicant: Spacelabs Healthcare, Ltd..

Clearance details

Applicant: Spacelabs Healthcare, Ltd.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2021-07-26
Decision date: 2022-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hertford, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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