SIGMA DELTA— 510(k) K002343

Name: FDA 510(k) clearance K002343
Creator: U.S. Food and Drug Administration
Published: 2001-06-08

Substantially Equivalent

Penlon , Ltd.

FDA 510(k) clearance K002343 for SIGMA DELTA, Substantially Equivalent on 2001-06-08. Applicant: Penlon , Ltd.. Device class: 2.

Clearance details

Applicant: Penlon , Ltd.
Product code: Code CAD
Device class: Class 2
Regulation: 21 CFR 868.5880
Advisory panel: Anesthesiology
Date received: 2000-08-01
Decision date: 2001-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barton Lane, Abingdon, GB

Download summary PDF View on FDA.gov ↗

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K150167 — V60 Anesthetic Vaporizer2015-06-30
K110608 — SEVOFLURANE VAPORIZER ADAPTOR2011-07-20
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More clearances from Penlon , Ltd.

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K061102 — PRIMA ANAESTHESIA MACHINE2006-07-28
K041076 — DELTA T2004-08-09
K010317 — AV 800 VENTILATOR2001-07-23
K010318 — PRIMA OXYGEN MONITOR2001-07-23
K961468 — QUIK-FIL VAPORIZER KEYED FILLER1996-07-16

Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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 →

Recalls naming K002343

K-number listed on FDA's recall record

Z-1653-2013 — Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.Class II·Terminated·Penlon, Ltd.·20130514

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002343.

Data sourced from openFDA. This site is unofficial and independent of the FDA.