Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list O-Two Systems International, Inc. with 15 510(k) clearances. The most recent is a 510(k) clearance dated Jun 26, 2003: SMART BAG MO.
| Jun 26, 2003 | SMART BAG MOK021328 · BTM | 510(k) clearances |
| Apr 22, 1999 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATVK991195 · BTL | 510(k) clearances |
| Nov 4, 1998 | AUTOVENT 1500K983857 · BTL | 510(k) clearances |
| Oct 29, 1998 | GENESIS BLSK983643 · BTL | 510(k) clearances |
| Oct 29, 1998 | EMT RESUSCITATORK983705 · BTL | 510(k) clearances |
| Oct 29, 1998 | AUTOVENT 1000K983785 · BTL | 510(k) clearances |
| Jan 7, 1997 | CPR BIO-BARRIER FACESHEILDK960995 · CBP | 510(k) clearances |
| Nov 14, 1994 | PPM IIIK940712 · CBP | 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
