NEOVO2R VENTILATORY— 510(k) K885243

Substantially Equivalent

Neomed

FDA 510(k) clearance K885243 for NEOVO2R VENTILATORY, Substantially Equivalent on 1989-07-24. Applicant: Neomed.

Clearance details

Applicant: Neomed
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1988-12-22
Decision date: 1989-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, N5v 3r6, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.