VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01— 510(k) K102626

Name: FDA 510(k) clearance K102626
Creator: U.S. Food and Drug Administration
Published: 2010-11-12

Substantially Equivalent

Vega Technologies, Inc.

FDA 510(k) clearance K102626 for VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01, Substantially Equivalent on 2010-11-12. Applicant: Vega Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Vega Technologies, Inc.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2010-09-13
Decision date: 2010-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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K031413 — VIGORMIST COMPRESSOR NEBULIZER2003-10-07
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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.