NUFFIELD ANESTHESIA VENTILATOR SER. 400— 510(k) K803052

Name: FDA 510(k) clearance K803052
Creator: U.S. Food and Drug Administration
Published: 1981-01-07

Substantially Equivalent

Penlon, Inc.

FDA 510(k) clearance K803052 for NUFFIELD ANESTHESIA VENTILATOR SER. 400, Substantially Equivalent on 1981-01-07. Applicant: Penlon, Inc.. Device class: 2.

Clearance details

Applicant: Penlon, Inc.
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 1980-12-02
Decision date: 1981-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K936046 — SIGMA ELITE1994-11-04
K902381 — PENLON BREATHING SYSTEM PRESSURE MONITOR1990-08-17
K894689 — PENLON IDP PRESSURE FAILURE ALARM1989-08-10
K844007 — PENLON PPV VAPORIZER1985-03-12
K844008 — PENLON AM1000 ANAESTHESIA MACHINE1985-03-12

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.