510(k) K060265— REMCORE REMOTE CONTROLLED OXYGEN REGULATOR

Substantially Equivalent

Remcore, Inc.

Clearance details

Applicant: Remcore, Inc.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 2006-02-01
Decision date: 2006-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.