Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of OSI SystemsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Spacelabs Medical with 35 510(k) clearances. The most recent is a 510(k) clearance dated Mar 29, 2012: SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390.
| Mar 29, 2012 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390K120616 · MHX | 510(k) clearances |
| Nov 2, 2011 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K112962 · MHX | 510(k) clearances |
| Dec 7, 2010 | SPACELABS MEDICAL PATIENT MONITORSK102422 · MHX | 510(k) clearances |
| Nov 24, 2009 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK093501 · MHX | 510(k) clearances |
| Aug 1, 2008 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K082045 · MHX | 510(k) clearances |
| Mar 15, 2007 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810K063490 · DQK | 510(k) clearances |
| Sep 29, 2006 | MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K062095 · MHX | 510(k) clearances |
| Sep 19, 2006 | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847K062278 · MSX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
