Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-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 14, 2026, FDA's public records list Phasein with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 25, 2012: IRMA C02 MODEL 200101; IRMA AX 200601.
| Oct 25, 2012 | IRMA C02 MODEL 200101; IRMA AX 200601K123043 · CCK | 510(k) clearances |
| Apr 6, 2011 | ISA CO2, ISA AX+, ISA OR+K103604 · CCK | 510(k) clearances |
| Sep 4, 2008 | VEO MULTIGAS MONITOR FOR POCKET PCK081601 · CCK | 510(k) clearances |
| Dec 28, 2007 | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)K072813 · CCK | 510(k) clearances |
| Feb 6, 2007 | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)K063167 · CCK | 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
