PRESSURE REGULATOR— 510(k) K853039

Name: FDA 510(k) clearance K853039
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Erie Medical

FDA 510(k) clearance K853039 for PRESSURE REGULATOR, Substantially Equivalent on 1986-04-11. Applicant: Erie Medical. Device class: 1.

Clearance details

Applicant: Erie Medical
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1985-07-19
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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 Erie Medical

view all

K861865 — ERIE-NEB1986-07-01
K853051 — TRACHEAL TUBES1986-04-11
K853040 — PRESSURE GAUGE1985-10-10
K832466 — TRACHEAL TUBE 16 GAUGE-1.65MM-1984-09-19

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.