FDA applicant
Optovent AB
FDA records 2 decisions for Optovent AB (Fort Lee, NJ) from 1999 to 2001: 2 510(k) clearances. All are in product code BZQ (Monitor, Breathing Frequency). No recall is linked to its devices.
FDA’s records also spell it “Optovent, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Optovent AB’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Optovent AB since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Optovent AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report