Spacelabs Healthcare, Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Eclipse MINI Model 98900510(k)Nov 7, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 7, 2022
Eclipse PRO510(k)Nov 22, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2021
Spacelabs Lifescreen PRO Analyzer510(k)Mar 26, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 26, 2021