OXYGEN REGULATOR— 510(k) K950777

Name: FDA 510(k) clearance K950777
Creator: U.S. Food and Drug Administration
Published: 1995-04-14

Substantially Equivalent

Mada Medical Products, Inc.

FDA 510(k) clearance K950777 for OXYGEN REGULATOR, Substantially Equivalent on 1995-04-14. Applicant: Mada Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Mada Medical Products, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1995-02-21
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlstadt, NJ, 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
K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR2006-10-25
K061785 — CYL-FIL OXYGEN SYSTEM2006-09-07
K942751 — VANGUARD SERIES GAS REGULATORS1995-02-09

More clearances from Mada Medical Products, Inc.

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K003862 — MADA WHEELCHAIRS2001-01-12
K002943 — WHEELCHAIR, MECHANICAL SERIES MODEL 31002000-10-23
K930947 — PROMENADE1993-06-01
K930949 — VOYAGE1993-06-01
K921611 — MADAVAC 1901992-09-09

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.