SOMA SAFE ENCLOSURE— 510(k) K963701

Name: FDA 510(k) clearance K963701
Creator: U.S. Food and Drug Administration
Published: 1997-01-24

Substantially Equivalent

Nova Technology Corp.

FDA 510(k) clearance K963701 for SOMA SAFE ENCLOSURE, Substantially Equivalent on 1997-01-24. Applicant: Nova Technology Corp.. Device class: 2.

Clearance details

Applicant: Nova Technology Corp.
Product code: Code FNL
Device class: Class 2
Regulation: 21 CFR 880.5100
Advisory panel: General Hospital
Date received: 1996-09-16
Decision date: 1997-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.