PRIMA OXYGEN MONITOR— 510(k) K010318

Name: FDA 510(k) clearance K010318
Creator: U.S. Food and Drug Administration
Published: 2001-07-23

Substantially Equivalent

Penlon , Ltd.

FDA 510(k) clearance K010318 for PRIMA OXYGEN MONITOR, Substantially Equivalent on 2001-07-23. Applicant: Penlon , Ltd.. Device class: 2.

Clearance details

Applicant: Penlon , Ltd.
Product code: Code CCL
Device class: Class 2
Regulation: 21 CFR 868.1720
Advisory panel: Anesthesiology
Date received: 2001-02-02
Decision date: 2001-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxfordshire, GB

Download summary PDF View on FDA.gov ↗

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K961468 — QUIK-FIL VAPORIZER KEYED FILLER1996-07-16

Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.