Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Spacelabs Healthcare, Ltd.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2022-11-07
TypeNumberDevice NameCodeDateActions
510(k) K212317 Eclipse MINI Model 98900MWJ2022-11-07 View
510(k) K211651 Eclipse PROMWJ2021-11-22 View
510(k) K201921 Spacelabs Lifescreen PRO AnalyzerDQK2021-03-26 View
510(k) K152881 SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEMDQK2016-04-01 View