SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12— 510(k) K071221

Name: FDA 510(k) clearance K071221
Creator: U.S. Food and Drug Administration
Published: 2007-09-06

Substantially Equivalent

Automedx, Inc.

FDA 510(k) clearance K071221 for SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12, Substantially Equivalent on 2007-09-06. Applicant: Automedx, Inc.. Device class: 2.

Clearance details

Applicant: Automedx, Inc.
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 2007-05-02
Decision date: 2007-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germantown, MD, US

Download summary PDF View on FDA.gov ↗

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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.