AUTOVENT MODEL 4000— 510(k) K070120

Substantially Equivalent

Allied Healthcare Products, Inc.

FDA 510(k) clearance K070120 for AUTOVENT MODEL 4000, Substantially Equivalent on 2007-05-03. Applicant: Allied Healthcare Products, Inc..

Clearance details

Applicant: Allied Healthcare Products, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2007-01-12
Decision date: 2007-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

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.