510(k) K211651— Eclipse PRO

Substantially Equivalent

Spacelabs Healthcare, Ltd.

Clearance details

Applicant: Spacelabs Healthcare, Ltd.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2021-05-28
Decision date: 2021-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hertford, GB

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.