VIGORMIST COMPRESSOR NEBULIZER

Compressor, Air, Portable

VEGA TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Vega Technologies, Inc. with the FDA for Vigormist Compressor Nebulizer.

Pre-market Notification Details

• Device ID: K031413
• 510k Number: K031413
• Device Name: VIGORMIST COMPRESSOR NEBULIZER
• Classification: Compressor, Air, Portable
• Applicant: VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104
• Contact: Joseph Lu
• Correspondent: Tzu-wei Li; CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW
• Product Code: BTI
• CFR Regulation Number: 868.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2003-05-05
• Decision Date: 2003-10-07
• Summary: summary

NIH GUDID Devices

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