PORTABLE GASEOUS OXGYEN CONTAINER— 510(k) K852663

Name: FDA 510(k) clearance K852663
Creator: U.S. Food and Drug Administration
Published: 1985-08-29

Substantially Equivalent

Cryogenic Assoc.

FDA 510(k) clearance K852663 for PORTABLE GASEOUS OXGYEN CONTAINER, Substantially Equivalent on 1985-08-29. Applicant: Cryogenic Assoc.. Device class: 1.

Clearance details

Applicant: Cryogenic Assoc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1985-06-24
Decision date: 1985-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAN

view all

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
K950777 — OXYGEN REGULATOR1995-04-14

More clearances from Cryogenic Assoc.

view all

K883590 — OXYTROL1988-11-02
K841808 — STROLLER SPRINT1984-05-16
K822789 — ROOMATE II1982-10-15
K800742 — LIBERATOR/STROLLER II SYSTEM1980-05-23
K801104 — ROOMMATE-OXYGEN CONCENTRATOR1980-05-23

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.