SAV-A-LIFE— 510(k) K844622

Name: FDA 510(k) clearance K844622
Creator: U.S. Food and Drug Administration
Published: 1985-02-26

Substantially Equivalent

Southern Medical Products, Inc.

FDA 510(k) clearance K844622 for SAV-A-LIFE, Substantially Equivalent on 1985-02-26. Applicant: Southern Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Southern Medical Products, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1984-11-27
Decision date: 1985-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cape Coral, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.