SELECT FLOWMETER— 510(k) K854067

Name: FDA 510(k) clearance K854067
Creator: U.S. Food and Drug Administration
Published: 1985-10-29

Substantially Equivalent

Precision Medical, Inc.

FDA 510(k) clearance K854067 for SELECT FLOWMETER, Substantially Equivalent on 1985-10-29. Applicant: Precision Medical, Inc.. Device class: 1.

Clearance details

Applicant: Precision Medical, Inc.
Product code: Code CAX
Device class: Class 1
Regulation: 21 CFR 868.2340
Advisory panel: Anesthesiology
Date received: 1985-10-04
Decision date: 1985-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bath, PA, US

Download summary PDF View on FDA.gov ↗

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K884973 — FR6000 FLOWMETER1989-01-17
K872718 — SERIES D FLOWMETER1987-08-05
K871452 — CLASSIC (TM) 200 OXYGEN FLOWMETER1987-06-22

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Adverse events under product code CAX

product code CAX

Death: 3
Other: 1
Total: 4

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.