AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR— 510(k) K883483

Name: FDA 510(k) clearance K883483
Creator: U.S. Food and Drug Administration
Published: 1988-10-07

Substantially Equivalent

Autoflow Products, Co.

FDA 510(k) clearance K883483 for AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR, Substantially Equivalent on 1988-10-07. Applicant: Autoflow Products, Co.. Device class: 1.

Clearance details

Applicant: Autoflow Products, Co.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1988-08-16
Decision date: 1988-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

Download summary PDF View on FDA.gov ↗

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K950777 — OXYGEN REGULATOR1995-04-14

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.