REMCORE REMOTE CONTROLLED OXYGEN REGULATOR— 510(k) K060265

Name: FDA 510(k) clearance K060265
Creator: U.S. Food and Drug Administration
Published: 2006-10-25

Substantially Equivalent

Remcore, Inc.

FDA 510(k) clearance K060265 for REMCORE REMOTE CONTROLLED OXYGEN REGULATOR, Substantially Equivalent on 2006-10-25. Applicant: Remcore, Inc.. Device class: 1.

Clearance details

Applicant: Remcore, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 2006-02-01
Decision date: 2006-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAN

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K162811 — MR Conditional CGA 8702017-03-02
K080243 — PORTABLE OXYGEN UNIT SCA9002009-04-07
K061785 — CYL-FIL OXYGEN SYSTEM2006-09-07
K950777 — OXYGEN REGULATOR1995-04-14
K942751 — VANGUARD SERIES GAS REGULATORS1995-02-09

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.