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, Inc. with 46 510(k) clearances. The most recent is a 510(k) clearance dated May 31, 1996: SPACELABS MEDICAL MULTIGAS ANALYZER.
| May 31, 1996 | SPACELABS MEDICAL MULTIGAS ANALYZERK954962 · CBR | 510(k) clearances |
| Jul 14, 1995 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK951605 · DSH | 510(k) clearances |
| Apr 25, 1995 | HEART RATE VARIABILITY SOFTWARE OPTIONK950779 · DPS | 510(k) clearances |
| Oct 6, 1994 | COMET CAPNOGRAPH MODULEK941165 · CCK | 510(k) clearances |
| Dec 6, 1993 | SPACE LABS MODEL 90560K923788 · LOS | 510(k) clearances |
| Apr 20, 1992 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEK912742 · FLL | 510(k) clearances |
| Oct 4, 1991 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATIONK913038 · DSH | 510(k) clearances |
| Apr 12, 1991 | DEFIBRILLATOR LEAD ADAPTERK905065 · LDD | 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
