LSPI AUTOMATIC VENTILATOR, MODEL AV3000— 510(k) K932199

Name: FDA 510(k) clearance K932199
Creator: U.S. Food and Drug Administration
Published: 1993-11-24

Substantially Equivalent

Life Support Products, Inc.

FDA 510(k) clearance K932199 for LSPI AUTOMATIC VENTILATOR, MODEL AV3000, Substantially Equivalent on 1993-11-24. Applicant: Life Support Products, Inc.. Device class: 2.

Clearance details

Applicant: Life Support Products, Inc.
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1993-05-06
Decision date: 1993-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Life Support Products, Inc.

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K941870 — LSPI AUTOMATIC VENTILATOR, MODEL AV2000-1001995-01-09
K941871 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000-1001995-01-09
K940934 — LIFE VAC1994-05-03
K936187 — LSPI PRESSURE REGULATOR1994-01-27
K922691 — LSP (MODEL 554) BAG MASK RESUSCITATOR1993-11-24

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.